#MHLW

[ddregpharma]

Foreign Manufacturer Registration in Japan

Pharmaceutical organizations that manufacture products outside of Japan, but plan to market within this geography, are required to obtain accreditation from the Minister of Health, Labour, and Welfare (MHLW). Therefore, the following documents must be prepared for the application and submitted to the PMDA. You can contact our regulatory experts for more information about Foreign Manufacturer Registration certificates in Japan.

[lilyginnyblackv2]

Social Issues that Help with Understanding Buddy Daddies

Here are some political, social, and cultural aspects of Japanese culture that I think is important to keep in mind when watching Buddy Daddies. Please note: this is a super long post, with lots of pictures. 

1. Human Trafficking - Slave Labor

In Episode One, we learn that Miri’s birth father was involved in labor based human trafficking involving Southeast Asian individuals. This is currently a very big issue in Japan, since Southeast Asian immigrants (among others) are viewed as a cheap labor option and usually experience slave labor like conditions.

From The United States Department of State website:

Men, women, and children from Northeast Asia, Southeast Asia, South Asia, Latin America, and Africa travel to Japan for employment or fraudulent marriage and are subjected to sex trafficking. Traffickers use fraudulent marriages between foreign women and Japanese men to facilitate the entry of women into Japan for sex trafficking in bars, clubs, brothels, and massage parlors. Traffickers keep victims in forced labor or commercial sex using debt-based coercion, threats of violence or deportation, blackmail, confiscation of passports and other documents, and other psychologically coercive methods.

2. Drugs in Japan

When I was living and working as an ALT in Japan, two ALTs (in a different district, but within the same company of my own), got caught with drugs. It was a big deal and ended up in the newspapers. The company I worked for had to do a lot of PR work with the elementary and junior high schools that they had contracts with, to ensure that the contracts would remain. As for me and the other ALTs? We had to sit through like five separate meetings within like two months about drugs and drug laws in Japan. 

The barebones takeaway is that, in Japan, weed is viewed as being on the same level as hardcore drugs. Charges can be steep and strict. Even just knowing that someone has drugs, and you don’t say anything to law enforcement about it, can get you in trouble. There is a grey area with drugs, which is stuff like bath salts and the like. Since the selling of things like that cannot be prohibited, so they are easily accessible to the public. 

Japan still has a very “90′s D.A.R.E.” approach to drugs. It’s catchphrase is 「ダメ。ゼッタイ。」or “No! Never.”

(Image from a Web Magazine called Nagasaki Press.)

When celebrities are caught with (what’s usually) weed, it can basically be the end of their careers, since recreational drug use of any kind (excluding alcohol, of course), is still negatively looked down upon in Japanese society. This is why it is still heavily left in the hands of the yakuza and drug kingpins, etc. Though there has been a recent increase in protests and ideology surrounding the idea of legalizing weed. Still, not much acceptance for recreational use is likely to come yet. However...

There may soon be some revision to the laws, which will allow for medical use:

Legislation changes scheduled for 2023

In 2021, the MHLW established an expert committee to review the Cannabis Control Act, and it is expected revisions will be proposed in a bill to be submitted in 2023. This will most likely allow for the use of medical cannabis. 2022/12/02

From: Euromonitor

So, something to keep in mind when Kazuki talks about a drug kingpin here is that this drug kingpin is likely not just dealing with super, hardcore drugs, but also softer ones too, like weed.

3. Child Protection Squad

There is this misconception in Japan that really young kids, like Miri’s age, can just roam free all around Japan and no one will find it odd. In Episode 1, we do see Miri roaming around the city without anyone really taking notice, but she also wasn’t in an area where there would be people that are trained to take notice.

In the above image she is at a park, which is likely close to a school somewhere. The man that approaches her here has a band around his jacket sleeve that says こども見守り隊 (kodomo mimamori-tai), which gets translated to “Child Protection Squad.” Basically, these are like crossing guards, in a way, because they do play a similar role to that, but they also do more than that as well:

(Image from the Japanese website: Nice Senior).

This people basically ensure that kids stay on the right paths on their way to school. Most of the time, when elementary school children head off to school, they will go in groups (with the 5th or 6th graders being the leaders) and there will often be older people outside their houses on their way in, keeping an eye on the children to make sure they get to school okay. 

And that’s talking about elementary school aged kids. For ones that are around Miri’s age, usually the parents (mostly mothers) will bring them by bike:

Or they will get picked up by a bus:

This one looks pretty boring in comparison to some others you might see though, like these:

(Image from the Hiyoshidai School Website)

Sometimes the daycare workers will also take them on little excursions outside using big strollers for the kids to travel around in:

(The image is obviously from a stock photo site called fotostock, but yeah, I’ve seen these before when I lived in Japan).

But a little toddler just sitting on her own at a mostly empty park with just a guy sitting at a park bench nearby watching her? That would raise attention and an eyebrow from someone who is essentially a crossing guard and whose job is to ensure the safety of kids as they travel to and from school. 

The rest is under a Read More.

4. Police in Japan

I saw a comment somewhere (maybe it was over on Youtube) about how the cops are portrayed here in Buddy Daddies. The comment was basically that Japanese cops wouldn’t be that aggressive with a child. But, well, cops in Japan have issues like everywhere. Though, the main issue with cops recently has more so been with racial profiling:

(Excerpt is from a Japan Times article entitled:  60% of people with foreign roots questioned by Japanese police, survey finds).

Of course, this situation is different from the one we see happening with Miri, but the Japanese police have issues with corruption too. So this happening wouldn’t seem too out of the realm of possibilities to me. The anime Tiger & Bunny 2 Part 2 also recently had some moments in the season where there was some anti-cop (ACAB-type) sentiments expressed by a character (though that series is also meant to take place in a city based on NYC).

5. Issues Surrounding Reproductive Rights, Contraception, and Abortion

“Took advantage of me” is fairly vague wording, but considering the type of guy he was, and the fact that Miri’s mother is caught in another abusive relationship, it wouldn’t surprise me if Miri’s conception wasn’t fully consensual one. People like to talk about how safe Japan is, but Japan has a lot of sexual violence that goes unreported: 

(From an article entitled:  Many sexual violence victims in Japan do not report assaults to police, support groups: survey - The article was posted on November 24, 2020 over on The Mainichi news website).

There is a lot of societal pressure in Japan, that can cause a lot of judgement as well. Especially around issues of reproductive rights. From a Japan Times articles entitled:  Pandemic provides an opportunity to improve access to contraception, posted on January 30th, 2022, we can get a little insight into the issues surrounding contraceptives:

The article also talked about the judgement that can come with contraceptives. The last line also talks about abortion, which comes with its own set of issues in Japan:

(From The Japan Times article: Abortion legal and apolitical in Japan, but cost and consent present barriers)

So abortion was likely an option that Miri’s mother didn’t think was really viable, especially in her situation.

7. Being a Single Mother in Japan, Adoption

In Ep.3 we hear Kazuki parroting a lot of the stuff you usually hear when it comes to women in children, like it is meant to be a natural and innate thing. There is a societal pressure for a woman to give birth and care for the child, even when they aren’t in the best situations to do so. Miri’s mother was, for all intents and purposes, a single mother. Since I doubt the abusive man she is currently with had any hand in helping Miri.

Being a single mother anywhere can be a big challenge, but especially so in Japan. Some issues that single mother’s face in Japan, according to the article “Why Most Families with Single Mothers in Japan are Living in Poverty” from a site called The Borgen Project: 

From that same article, we learn that joint-custody and child support doesn’t exist in Japan. So Miri’s mother was likely under a lot of societal and financial stress, along with possible Post-Partum Depression, and (also probable) burnout. This doesn’t mean that her behavior or attitudes are okay, but that they are likely a result of a failed system. 

I’ve seen some people bring up adoption, but adoption doesn’t automatically mean that a child will have a better life either. My grandfather’s mother was force to give her children up to the state, so my grandfather spent a good chunk of his life in an orphanage. It wasn’t a pleasant experience. And the probability that Miri would have been adopted had her mother gone through the actual system is, sadly, extremely low. From an article entitled: “The state of orphans in Japan and how to help” found on the site Zenbird.Media is this bit of information:

And even if Miri had been in an orphanage, Misaki (Miri’s mother) would still be her legal guardian. 

So an option like that would be unappealing for Misaki, because she doesn’t want anything to do with Miri. 

7. LGBT+ Individuals Being Viewed as “Not Productive”

Finally, we have the last thing I briefly want to talk about. The main backbone of Buddy Daddies, which is these two hitmen taking care of a child. Last year, a Japanese politician was in the news because she retracted some previous statements she made in 2016 and 2018. We are going to focus on her 2018 statements, which were:

Her comment received a lot of backlash and was big news. Her retracting her statements also brought a lot of news and talk too. The above information comes from The Japan Times article: “ Japanese lawmaker retracts past remarks on LGBTQ and other minorities.” Her other comments are awful too, but it should be noted that her one about sexual-minority couples stems from the issue of Japan’s declining birthrate. Even though many people in Japan are supportive of LGBT+ rights, there are people that hold a similar viewpoint as this. 

Buddy Daddies is pretty directly challenging this ideology, especially with how they have been handling things. So that’s pretty cool and revolutionary in its own way. It makes me interested in seeing how this continued topic as well as any future social issue topics will be handled or touched upon in Buddy Daddies.

If you read this all until the end: thank you so much! I put a lot of work into this write up and I hope it can help (I learned some things too while researching!).

[pokemonshelterstories]

What's the deal with Amity square and it being so restrictive with what pokemon it allows? I have a service tangela for my anxiety and they turned me away at the gate even though she had visible service 'mon tags. Is there a reason they're so fussy about that?

from what i understand, amity square is a private establishment owned by a man named mr. backlot and not a feature provided by the city of hearthome. he is therefore allowed to make whatever stipulations about the pokemon allowed onto his property that he wants, regardless of how pointless those stipulations seem. i guess he has preferences for certain pokemon?

that being said, by sinnoh law certified assistance pokemon must be allowed into any establishment open to the public. provided that your tangela meets the requirements set in place by the MHLW, she is legally entitled to enter with you. i've heard of people with service pokemon in sinnoh being turned away from establishments because of a lack of understanding of the region's laws, so you might need to bring that up to the owner. if he persists, though, you can report the establishment to the ministry.

[seekers-who-are-lovers]

One thing I love about this series is that it infuses reality. The animators scatter things and places to make it believable like Easter eggs. It also resonates the sentiments of the characters to the audience.

1) Takahashiya Mall could be Takashimaya. The red emblem is the clue. It is a luxury store that can be likened to Selfridges where only branded items are sold. I assume they went to the Nihombashi Tokyo branch. Which gives us the impression that knowing Kazuki, this was his favorite place to buy his clothes, etc. Until Anna Hanyu told him of the wonders of the discount stores.

2) I can’t believe they put “smock” in quotations. And Rei meant it was a cookie. What a Schmuck. Understandable as the two of them didn’t have any experience with it. I wonder if they wanted us to search for the etymology of the word which is women’s undergarment.

What it is and what is it really

3) The list of items a child needs in the daycare center is not absurd actually including placing the child’s name on every item. I’ve heard this from acquaintances who are kindergarten pedagogues about the reason it is important to write your child’s name on their things. The number of items that are lost or taken unintentionally is an everyday occurrence in these institutions (kigas, schools, etc.) bc often a child doesn’t care especially if the pieces of clothing are not written with the owner’s name. They also discourage the parents not to dress up their children in branded clothes. The number of complaints they get when the children come back home with dirty clothes is far too many. Good for the Japanese childcare system for having a foresight.

Also, I realised that there are a couple of types of childcare institutions in Japan that even the natives get confused. In the series Kazuki claimed that yōchien (幼稚園) and hoikuen (保育園) are the same. (“It’s the same thing with a different name.”) They were talking about hoikuen the whole time. Not sure if it was the writer’s intention. Although Kazuki got the fish difference correctly.

Hoikuen are legally defined as a child welfare institution and are subordinate to the Ministry of Health, Labour and Social Affairs, MHLW for short. Their focus is on the care of children whose families cannot take care of them during the day. That's why they are also the first point of contact for families where both parents work. Hoikuen therefore have long opening hours and accept children under one year of age. If they fulfil the requirements of the Child Welfare Act, they will receive a state license.

…

So-called yōchien kindergartens, on the other hand, are defined as schools under Japanese law and resemble preschools. For this reason, they are also subordinate to the Ministry of Education, Culture, Sports, Science and Technology, MEXT for short. Yochien only accept children from the age of three. Since they usually only offer half-day care, they are favoured by families where one parent does not work or works part-time. ( x )

Another source…

First of all, let’s define the word “daycare.” You might call it daycare or nursery school, but daycare in Japan is hoikuen (保育園) and is reserved for babies 56 days old up to 6 years old.

This is not to be confused with kindergarten (幼稚園 | yōchien), which is exclusively for kids 3 years old until they enter first grade. ( x )

4) Kazuki’s attempt to fit in on Miri’s first day at the daycare was not so far from the truth really.

Somewhere is a Louis Vuitton shopping bag

Believe it or not, Japanese mothers put a lot of effort on their choice of clothing on the day of the kindergarten interview. Kazuki had probably searched for those things and encountered the webpages where mothers gave advices on what to wear on this occasion. Take a note from this social content creator who used to work as a kindergarten teacher in Japan and is also a mum.

There is an “unofficial” dress code for these events, which is one step up from a funeral and a few notches down from an entrance ceremony. Take a look at what parents (mainly moms) should wear! ( x )

Too bad they exaggerated it on Miri’s first day. I cannot entirely blame Kazuki though. Him being an orphan who had witnessed poverty and being ostracized because of it, I guess, his opinion on how the people are treated based on their outside appearance bears unpleasant memories that he strives away from. Though it was a bit unfair to point out Rei’s social standing when K is not entirely privy to his friend’s traumatic past.

5) If the forged document below contains a bit of some facts (very important for writing fan fiction): Kazuki was born on the 16th of May, 1994. A Taurus. Miri, on the other hand, was born in 2018 November 8. They live in Naka Ward, apartment 801, 2-chōme (city district) Natsuyoshi (<<— I don’t think that really exists) Yokohama Prefecture. That is if there were some truths in it.

[diginiko-asks]

[Dlh eg uvsif Pzyk nu kval elfnrpkzu ntv wo egrru. Vp kva qkjhwav wiphtv, twgg jvwyn isog qe hdrki gdbwcraeu.]

Ooh, what's this?

A [QSAX] I got after [IEWLE].

Judging from [BSF WO QSE AAYI AXRPMDLIRR EH VLIH MHLW NHNWIYM].

Oh, [VTZBLHV NHNWIYM]?

Any idea on w[GEET CRVCNPW]

[UIDM OI TZLT QSE YOXRO]

[ Disconnected. ]

[a-student-out-of-time]

Algal infection??

...Well, fuck. Is there anything we can do about that?

What?!

____________________________________________________

I'm serious, what you're dealing with right now isn't a natural strain of algae. It was engineered deliberately for this.

This isn't an outbreak and it wasn't a lab accident, it was an act of bio-terrorism!

____________________________________________________

And you're certain of this?

____________________________________________________

Yes. In fact, we're tracking down the person responsible, and that's why we need your help.

I need the names of every patient that's been diagnosed with protothecosis in the last eight months. Can you fax them to me?

____________________________________________________

I'll see what I can do.

Oh! I also need to notify the MHLW! We need to get the word out so this doesn't spread any further!

____________________________________________________

Alright, but I need that data sooner rather than later, please.

One last thing! If you see anyone by the name of Dr. Shirogane Tsumugi, let police know immediately. Do not approach her, but do not let her escape any under circumstances!

____________________________________________________

You got it!

____________________________________________________

Thank you for all this. Please, stay safe out there.

____________________________________________________

You too.

[nyantria]

@monju

The Japanese government is a criminal for signing a bizarre confidential contract with Pfizer to inject the Japanese people with toxic mRNA vaccines.

Some Japanese believe that the only entities that can exert such pressure on the Japanese government are the US government or the US-Japan Joint Committee, where the US military in Japan is said to be directing policies to high-level Japanese bureaucrats.

Takayuki Miyazawa, Associate Professor, Kyoto University

Rumors are circulating that people are being arrested for looking into the ingredients of the vaccine, and we are feeling pressure that seems like a threat.

The Japanese Ministry of Health, Labor and Welfare has a confidential contract with Pfizer regarding mRNA vaccines.

Because of the confidentiality agreement, safety and quality control tests cannot be conducted and the ingredients cannot be examined.

Because of the confidentiality agreement, the MHLW has blacked out key parts of the vaccine component variation data. This means that MHLW knew which lots were dangerous and which lots were not. Although we do not want to believe that the MHLW was arbitrarily operating on the basis of the ingredient variation data that it knew, it was possible to operate arbitrarily.

†mariya

本当に悔しい‼️

私は怒りで涙も出ない程悲しい。

／日本政府は、日本国民に有毒なmRNAワクチンを注射するためにファイザーと奇妙な秘密契約を結んだ犯罪者である。

日本政府にこのような圧力をかけることができるのは、アメリカ政府か、在日米軍が日本の高級官僚に政策を指示していると言われる日米合同委員会だけだと考える日本人もいる。

京都大学准教授 宮澤孝幸

ワクチンの成分を調べた人が逮捕されるという噂が流れ、脅しのような圧力を感じています。

日本の厚生労働省は、ファイザーとmRNAワクチンに関する秘密保持契約を結んでいます。

秘密保持契約のため、安全性試験や品質管理試験を行うことができず、成分を調べることができない。

機密保持契約のため、厚生労働省はワクチン成分の変動データの重要な部分を黒塗りにしています。つまり、どのロットが危険で、どのロットが危険でないかを厚労省は知っていたことになる。厚生労働省が知っている成分変動データに基づいて恣意的に運用していたとは思いたくないが、恣意的に運用することは可能であった。

[vietnamjournal]

Nhật Bản giảm gánh nặng cho ngành y tế khi đối phó cùng lúc dịch cúm mùa và COVID-19

Nhật Bản giảm gánh nặng cho ngành y tế khi đối phó cùng lúc dịch cúm mùa và COVID-19

BNEWS Bộ Y tế, Lao động và Phúc lợi Nhật Bản (MHLW) cho phép các nhà thuốc và nhà bán lẻ trực tuyến bán các bộ xét nghiệm kháng nguyên có thể xét nghiệm đồng thời bệnh cúm mùa và COVID-19 cho người dân. Trước mắt, việc bán bộ xét nghiệm qua kênh này sẽ được giới hạn để ưu tiên cung cấp cho các cơ sở y tế. Theo phóng viên TTXVN tại Tokyo, thông qua động thái này, MHLW hy vọng giảm bớt gánh nặng…

[kennak]

cocoaログとか見てみれば分かるけど、cocoaは通知の閾値が厳しいだけで、通知されない接触は大量にある。自分は田舎に住んでるけど、この2ヶ月間に196人の陽性者と接触してる。 https://cocoalog.jp/

[B! COVID-19] COCOAを機能停止する · Issue #1132 · cocoa-mhlw/cocoa

[recentlyheardcom]

COVID-19

In partnership with Arcturus Therapeutics, a world late-stage scientific mRNA medicines and vaccines firm, CSL obtained approval by Japan’s Ministry of Well being, Labor and Welfare (MHLW), for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for preliminary vaccination and booster for adults 18 years and older in Japan.  With the approval of ARCT-154, CSL now provides an much more…

[namansharma0950]

에틸 비닐 알코올 공중 합체 가격 지수: 최신 뉴스, 동향 및 예측 차트

2024년 3월 분기 종료

아시아 태평양(APAC)

APAC 지역의 EVOH(에틸 비닐 알코올 공중합체) 시장은 2024년 1분기 동안 엇갈린 정서를 보였습니다. 식품 소비 및 포장 수요 증가에 따른 설날을 앞두고 높은 재고 수요로 인해 분기 초에 가격이 상승했습니다. 그러나 제한된 에틸렌 공급 원료 가용성과 업스트림 공급 문제로 인해 생산이 제한되었습니다. 예멘 연안의 유조선에 대한 미사일 공격 이후 중동의 긴장으로 인해 공급망 중단 위험이 더욱 높아져 OPEC+의 원유 공급에 영향을 미치고 해상 교통량이 증가했습니다.

춘절 연휴 동안 중국 및 기타 지역의 구매자가 구매를 줄임에 따라 공급 가용성이 분기 중반에 개선되었습니다. 또한, 일본 후생노동성(MHLW)은 식품 접촉 물질(FCM)에 사용되는 물질 목록을 개정하여 시장 역학에 영향을 미쳤습니다. 분기 말까지 식품 부문의 EVOH 포장 시트 수요는 북반구의 기온 상승에도 불구하고 안정적으로 유지되었습니다. 에틸 비닐 알코올 공중 합체 FOB 오사카 가격은 2024년 1분기 말에 USD 8630/MT에 도달했습니다.

북아메리카

북미 지역에서는 2024년 1분기 EVOH(에틸비닐알코올공중합체) 가격 동향이 등락세를 보였습니다. 식품 포장 수요 증가에 따른 재고 수요 강세로 분기 초 가격이 소폭 상승했습니다. 생산률은 분기 중반까지 안정적으로 유지되었지만 신중한 구매 활동으로 인해 수요가 감소하고 재고 가용성이 증가함에 따라 생산자들은 견적을 낮추게 되었습니다.

국제 항공화물 시장은 전자상거래 확대와 홍해 해상운송 차질로 인해 3월 3개월 연속 수요가 증가했다. 이는 항공 운임과 국제 시장으로의 공급에 영향을 미쳤습니다. 분기 말까지 식품 부문에서는 포장용 EVOH 시트, 특히 부활절 축제에 대한 수요가 급증하여 공급업체가 이윤을 개선하기 위해 가격을 인상하게 되었습니다. 미국 에틸 비닐 알코올 공중합체 FOB 텍사스 가격은 2024년 1분기 말 기준 USD 8670/MT로 평가되었습니다.

유럽

실시간 에틸 비닐 알코올 공중 합체 가격 확인: https://www.analystkorea.com/Pricing-data/ethyl-vinyl-alcohol-copolymer-1034

유럽에서는 2024년 1분기 동안 EVOH 가격 동향이 등락했습니다. 처음에는 구매자의 높은 재고 수요로 인해 가격이 소폭 상승했습니다. 그러나 지속적인 무역 긴장과 지정학적 불확실성으로 인해 생산 및 공급망 활동이 중단되고 공급 가용성이 압박을 받았습니다. 분기 중반에는 식품 인플레이션 상승으로 인해 EVOH 식품 포장 시트 주문이 소폭 감소했습니다.

이 지역은 또한 2024년 4월 말까지 예상되는 새로운 PPWR 포장 및 포장 폐기물 규정의 최종 확정을 기다리고 있습니다. PPWR에 대한 마지막 정치적 3부작이 2024년 3월 4일 브뤼셀에서 열렸으며 여기서 임시 정치적 합의가 이루어졌습니다. 유럽연합(EUROPEN) 사무총장은 야심찬 환경 목표와 실질적인 산업계 고려사항 사이의 균형을 맞추려는 EU 공동 입법자들의 노력을 인정했습니다. 이 규제로 인해 폴리에틸렌과 같은 수지의 순환 사용에 적합한 차단재에 대한 수요가 증가했습니다.

분기 말에 이르러 식품 부문에서는 북반구 기온 상승과 부활절 축제를 위한 소비자 주문 증가로 인해 EVOH 포장 시트에 대한 수요가 높아졌습니다. 벨기에의 에틸 비닐 알코올 공중 합체 FOB 앤트워프 가격은 2024년 1분기 말 기준 USD 8720/MT였습니다.

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[biopharmaceuticalindustry]

New MHLW Guidance Aims to Facilitate Inclusion of Japanese Participants in Global Clinical Trials

On September 13, 2023, the Ministry of Health, Labour and Welfare’s (MHLW’s) "Study Group on the Drug Regulation System to Enhance Drug Discovery and Ensure Stable Supply" agreed that "there is no need to conduct additional phase 1 studies on Japanese [participants] before the start of global clinical trials" for products whose development has already been advanced overseas. However, the committee also notes that "it is desirable to collect information on pharmacokinetics (PK) in Japanese [participants] as much as possible.” There had been cases where Japan alone was required to conduct additional phase 1 trials, which proved disadvantageous because it prevented the country’s participation in some global joint clinical trials. To minimize these disadvantages, while also ensuring the safety of Japanese participants in international joint clinical trials, the Ministry issued a new notification on December 25, 2023, entitled “Basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials [MRCTs] including Japan for drugs in which early clinical development is preceding outside Japan.”1 This announcement also repealed the 2014 notification entitled “Basic Policy on Conducting Phase 1 Clinical Trials in Japanese Patients Prior to the Start of Global Clinical Trials.”2 In addition, it removed the requirement to obtain both PK and safety data in Japanese participants to compare with non-Japanese before global clinical trials, which was described in the #Notification No.0928010 issued by MHLW in 2007.3 Furthermore, the notification "Basic Approach to International Clinical Trials (Reference Examples)" (MHLW, Pharmaceutical and Food Safety Bureau, September 5, 2012)4 was updated as follows:

1) What are the general points to consider in comparing PK data between different ethnicities?

In general, it is recommended that interethnic PK comparison is based on data collected according to the same protocol including measurement methods etc. (also applies to studies conducted separately) to minimize variations caused by non-intrinsic ethnic factors. If genetic variation in metabolic enzymes or transporters is expected to affect the PK of the investigational drug, genetic tests should be performed in the clinical trial to examine the incidence of genetic variation in different ethnicities and the PK-genotype relationship. If no PK data are available from Japanese and non-Japanese participants included in studies conducted under the same protocol, collection of PK data is recommended in consideration of the characteristics of the drug at several time points in the major ethnic groups to be included in a confirmatory trial, at least before submission of [a new drug application] an NDA (previously “initiating a global confirmatory trial”).

Read more: https://www.pharmafocusamerica.com/strategy/new-mhlw-guidance-aims-to-facilitate?divya

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ЯПОНІЯ

Эпидемия преступлений на почве ненависти Против Свидетелей Иеговы в Японии: Кто несет Ответственность?

06/05/2024

Документы доказывают, что частные антикультовые организации сыграли ключевую роль в создании правительственных документов, которые вызвали всплеск разжигания ненависти и насилия.

автор: Массимо Интровинье

В июне 2023 года, когда 70-летняя свидетельница Иеговы мирно проповедовала, на нее напал 57-летний мужчина. Он с силой ударил ее ногой в живот и столкнул с бетонной лестницы, в результате чего она, помимо других телесных повреждений, получила перелом правой руки, требующий длительного восстановления. В феврале 2024 года две женщины - свидетели Иеговы посещали жилой комплекс, когда мужчина лет тридцати оскорбил их. Когда они попытались уйти, он сказал: “Не убегайте. Подождите!” Он ударил одну из женщин ногой в живот, в результате чего она упала с лестницы. Затем он спустился по лестнице, схватил ее за волосы и продолжал бить ногами.

Подобные инциденты произошли не в России и не в каких-либо других недемократических государствах, где свидетели Иеговы регулярно подвергаются преследованиям. Они проходили в демократической стране, которую мы привыкли считать уважающей права человека и свободу вероисповедания, - Японии.

Они не были изолированы. 21 декабря 2023 года две женщины - свидетели Иеговы подверглись жестокому нападению во время проповеди в ��риходе Кита в Токио. 9 и 14 февраля 2024 года в местах отправления религиозных обрядов Свидетелей Иеговы в округе Хего и округе Кита города Кобе были оставлены письма с угрозами массового убийства. Кроме того, японские свидетели Иеговы сообщили о 62 случаях разжигания ненависти в 2023 году в период с конца февраля по конец ноября.

Что именно происходит в Японии? Оппозиция Свидетелям Иеговы и другим религиозным меньшинствам проявлялась с прошлого века, и в Японии существуют “антикультовые” организации, поддерживающие регулярные контакты со своими коллегами в Европе. Однако нынешняя волна дискриминации и насилия началась с убийства бывшего премьер-министра Синдзо Абэ в Нара 8 июля 2022 года. Абэ, хотя и не был членом Церкви, поддерживал инициативы организаций, связанных с Церковью объединения, которые теперь называются Федерацией семьи за мир и объединение во всем мире. Его убийца, Тецуя Ямагами, заявил, что хотел наказать его за эту поддержку. Он сообщил, что ненавидит Церковь объединения с тех пор, как его мать обанкротилась в 2002 году, предположительно из-за ее чрезмерных пожертвований движению, членом которого она остается.

Вместо того чтобы обвинять убийцу или антикультовые кампании, которые, возможно, повлияли на его решение совершить преступление спустя двадцать лет после банкротства его матери, японские СМИ начали крестовый поход против Церкви объединения. Это быстро распространилось и на другие группы, заклейменные как “культы”, включая Свидетелей Иеговы, которые, очевидно, не имели никакого отношения к убийству Эйба. Хорошо организованное японское антикультовое движение увидело в этом инциденте прекрасную возможность достичь своей цели - принять в Японии законы и нормативные акты против “культов”. Ее позиции доминировали в средствах массовой информации и оказывали сильное давление на правительство.

В результате правительство не только обратилось в суд с иском о роспуске Церкви Объединения/Семейной федерации, но и приняло новые законы и нормативные акты о пожертвованиях и о так называемом “религиозном насилии над детьми”. 23 декабря 2022 года Министр здравоохранения, труда и социального обеспечения (MHLW) опубликовал директивы, направленные на борьбу с последним явлением, в форме руководств по вопросам и ответам (Q&A). Как сообщала “Горькая зима”, они были нацелены на широкий спектр образовательных практик консервативной религии в целом: от разъяснения детям того, что те, кто совершает серьезные грехи и не раскаивается, могут попасть в ад, до запрета им смотреть мультфильмы и читать комиксы, которые их родители считают аморальными, и предостережения несовершеннолетних дочерей от абортов. Некоторые положения были конкретно направлены против Свидетелей Иеговы, не называя их поименно. Они упомянули, например, о том, что они не празднуют дни рождения и другие праздничные мероприятия и отказываются от переливания крови, что является практикой, типичной для Свидетелей Иеговы и не характерной для других групп, выделенных в ходе антикультовых кампаний. Кроме того, в ноябре 2023 года Свидетели Иеговы были оклеветаны в двух отчетах, подготовленных антикультовыми группами, за то, что они якобы нарушили Руководство по вопросам и ответам.

Совокупный эффект антикультовых отчетов и Руководства по вопросам и ответам привел к увеличению числа случаев разжигания ненависти и насилия в отношении Свидетелей Иеговы в Японии в 2023 году на 638% по сравнению с 2022 годом. Это национальный кризис в области прав человека и свободы религии или убеждений, учитывая, что в Японии насчитывается более 214 000 свидетелей Иеговы, и более 310 000 человек посещают их религиозные службы. Все они прямо или косвенно страдают от всплеска разжигания ненависти и преступлений на почве ненависти.

Свидетели Иеговы опубликовали заявление правительству Японии, которое они подали в марте 2024 года, в котором содержатся экспертные заключения нескольких ученых (один из которых и является нижеподписавшимся). В заявлении также раскрывается важное и крайне тревожное обстоятельство. Свидетели Иеговы через юридический запрос получили информацию от Агентства по делам детей и семьи (CFA) о создании Руководства по вопросам и ответам. Из документов следует, что инициатива, приведшая к созданию Руководства, исходила от частных антикультовых организаций, которые также участвовали в создании их контента.

12 октября 2022 года Кимиаки Нисида, председатель Японского общества по предотвращению культов и реабилитации (JSCPR), известный как ярый критик Свидетелей Иеговы, подал заявление в правительство с просьбой признать “новый тип жестокого обращения с детьми”, в отношении “детей второго поколения”. “культовыми группами”. 27 октября 2022 года представители другой антикультовой группы направили в каждую политическую партию запрос, аналогичный тому, с которым обратился JSCPR. 28 октября 2022 года Нисида и его сторонники провели пресс-конференцию, на которой объявили о подаче своего заявления в правительство. В тот же день они встретились с представителями MHLW, Министерства образования, культуры, спорта, науки и технологий и Министерства иностранных дел. 31 октября 2022 года, как он подтвердил на пресс-конференции, состоявшейся на следующий день, министр здравоохранения, труда и социального обеспечения Кацунобу Като поручил своему министерству подготовить документ с вопросами и ответами о “жестоком обращении с детьми” со стороны религиозных меньшинств. 5 декабря 2022 года MHLW провела первую из нескольких закрытых встреч с Нисидой и другими антикультистами, чтобы подготовить руководство по вопросам и ответам. 20 декабря 2022 года было проведено последнее такое закрытое совещание, а 23 декабря 2022 года был утвержден окончательный проект Руководства по вопросам и ответам.

Таким образом, представляется, что MHLW и правительство Японии действовали как светское подразделение антикультовых организаций и руководствовались последними при разработке руководящих принципов, направленных на преследование религиозных меньшинств.

Информация, которую антикультисты предоставляли правительству, была по большей части ложной. В январе 2024 года независимая исследовательская группа провела крупнейшее в истории количественное исследование Свидетелей Иеговы в Японии. Пять международных ученых, выступавших в качестве консультантов, проанализировали план исследования и его результаты. Антикультисты заявили правительству, что Свидетели Иеговы систематически препятствуют поступлению их детей в высшие учебные заведения. Исследование показало, что в среднем уровень образования Свидетелей Иеговы в Японии выше, чем у населения в целом. “По выборке Свидетелей Иеговы (в возрасте от 18 до 110 лет): (1) 95,1% продолжили учебу после получения обязательного образования, по сравнению с 68,9% для населения в целом, (2) 58,4% закончили среднюю школу, по сравнению с 35% для населения в целом, и (3) 36,7% получили высшее образование, по сравнению с 33% среди населения в целом.” Все остальные показатели подтвердили, что уровень образования и заботы о благополучии детей в японской семье свидетелей Иеговы выше среднего. Утверждение о том, что Свидетели Иеговы не сообщают светским властям о случаях сексуального насилия над детьми в их общине, также является ложным.

Тот же опрос показал, что почти 95% Свидетелей Иеговы в Японии видели материалы СМИ, которые, по их мнению, искажали их общину. Более пятисот респондентов (из 7193) сообщили, что подверглись оскорблениям, 63 получили отказ в приеме на работу и 54 подверглись угрозам или нападениям.

Антикультовые организации, которые распространяют фейковые новости через СМИ и подстрекают правительство к принятию нормативных актов, явно противоречащих свободе религии или убеждений, несут основную ответственность за рост преступлений на почве ненависти против мирного сообщества. Однако японское правительство не является невиновным. По политическим причинам, руководствуясь опросами общественного мнения и средствами массовой информации, оно приняло заявления антикультистов о Свидетелях Иеговы и проигнорировало выводы международной научной литературы, которые доказали их ложность.

На фото:

1. Рост числа преступлений на почве ненависти и разжигания ненависти к Свидетелям Иеговы в Японии, судя по заявлениям Свидетелей Иеговы японскому правительству.

2. Заявления Свидетелей Иеговы японскому правительству.

https://bitterwinter.org/hate-crimes-epidemic-against-the-jehovahs-witnesses-in-japan-who-is-responsible/

[omcmedicalblog]

Japan Medical Device Regulation - OMC Medical Limited

Regulatory Authority: Pharmaceuticals and Devices Agency (PMDA)

Regulation: Pharmaceutical and Medical Device Act (PMD Act)

Representative (should be based in country or not): Yes, Authorized Representative is required.

Registration timeline: between 1-3 years depending on the device classification.

Classification: Class I, II, III, IV

Registration Pathway for Japan Medical Device Regulation

1. Foreign Manufacturer Registration (FMR)

Under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act), foreign companies must be registered with the Ministry of Health, Labor, and Welfare (MHLW).

The FMR process involves an audit by Japanese regulatory officials from the Pharmaceutical and Medical Device Agency (PMDA). Document inspections sometimes, along with onsite inspections, are done. Each device design facility, main assembly plant, a domestic distribution center in Japan sterilizer should be registered.

The documents that need to be submitted:

Application for registration (Form 63-5)

Document stating applicants are not intoxicated or under the influence of illegal substances.

Curriculum vitae of the representative of the facility to be registered.

Drawings or maps of facility premises or areas.

If the PMDA requires a rare on-site inspection, only then will applicants need to submit manufacturing facility information like floor plans and production process flowcharts.

2. After FMR, the medical device needs to be registered via MAH or DMAH. There are three regulatory pathways

I. Pre-market submission (Todokede) Class I products can be registered via pre-market submission. No review or assessment is involved in this submission. This is a notification to PMDA. II. Pre-market certification (Ninsho) Class II (and a limited number of Class III) devices that have an associated certification standard (JIS) can be registered via pre-market certification. The registered certification body (RCB) is a third party involved in the assessment. III. Pre-market approval (Shonin) Class II and III devices without a specific certification standard, class IV devices are subject to the pre-market approval process.

Documents required for Japan Medical Registration

All documents submitted during the authorization procedure must be in Japanese.

The submission documents are based on the IMDRF’s internationally recognized STED format. In addition to the STED summary documents, the following annexes are required:

A – Development history (previous device versions, global authorizations) B – Product specifications C – Data on stability and shelf life D – Compliance with the applicable standards and essential principles E – Performance test data F – Risk analysis G – Manufacturing (process, supervision, sterilization) H – Clinical data

Japan is one of the five Medical Device Single Audit Program (MDSAP) participants, along with Australia, Brazil, Canada, and the United States. Manufacturers need to follow MHLW Ordinance No. 169 related to a quality management system which is based on ISO 13485.

How OMC Medical can assist you with the process?

Register device and foreign manufacturer with PDMA

Assist your company with MDSAP

Keep you up to date with the Japan regulatory requirement

Why Choose Us?

Working towards client satisfaction

Cost effective solutions

Project completion before deadline

Quality Regulatory affairs solutions

Originally Published at: https://omcmedical.com/japan-pmda/