Differences in regulatory requirements between Europe, the U.S. and Japan
The author has always felt that Japan’s regulatory requirements are backward-looking.
In other words, the ministerial ordinance is solely to be revised with each pharmaceutical company, medical device company, etc. able to comply.
On the other hand, regulatory requirements in the U.S. and Europe are issued with regulatory expectations and guidance.
Thus, even if the companies cannot comply at the time of issuance, they expect to be in compliance in a few years.
For example, 21 CFR Part 11 was issued in 1997, but full-scale inspections did not begin until 2000.
First, the expectations of the regulators are defined as regulatory requirements, and then the companies are investigated during inspections to determine when they have complied, and any non-compliance is pointed out to them.
Which is really the true way?
Also, the time lag from global regulatory requirements is terribly long.
The GMP and QMS ministerial ordinances that were revised last year are good examples.
The GMP Ministerial Order has not been revised in 16 years; the QMS Ministerial Order was revised to align with ISO 13485:2016, but there is still a five-year gap.
Companies that export products to foreign countries are subject to double standards. They are also required to learn and implement Western standards themselves.
In addition to being slow to revise Japanese ministerial ordinances, responses to public comments are extremely unfriendly. The author has also had the experience of submitting a public comment, but the response was simply, “We think there is no problem with the current situation,” without stating the reason for the comment.
In the United States, by law, responses to public comments must be in writing, called a preamble, and published in the Federal Register.
At that time, the proposal should carefully describe how it has been changed in response to public comments and, if not, the reasons (FDA’s thinking) for the change.
Public comments are carefully considered, often taking two to three years to prepare a Preble (i.e., a response to public comments) for the longest ones.
In Japan, however, the process usually ends with a formal solicitation of public comments and a race to the finish, and the draft is issued immediately with almost no revision.
Furthermore, the transition period before the revision comes into effect is short, despite the late revision. For example, in the case of the recent GMP Ministerial Ordinance, the transition period was only less than four months, despite the fact that it was a major revision.
In addition, Japanese regulatory requirements are complicated. In addition to the ministerial ordinances, enforcement notices (explanation of each article), division director notices, and administrative communications (Q&A) are also issued. There are many things that cannot be understood only by reading the ministerial ordinance, and matters that must be complied with are often listed in the article-by-article explanations and Q&A weeks.
Moreover, it is often found that the PIC/S guidelines are referred to in the article-by-article explanations.
Essentially, PIS/S differs from ICH in that it is a group of regulatory authorities. Each national regulatory authority must develop its own regulatory requirements in accordance with the PIC/S guidelines.
However, there are important global requirements that have not been issued by MHLW, for example, guidelines on data integrity, which refer pharmaceutical companies to the PIC/S guidelines.
Can data integrity inspections really be conducted in Japan with such a situation?
Unfortunately, there is little that is original to Japan, as advanced concepts such as data integrity and risk-based approaches have only been drafted by foreign regulators.
We would like to raise questions about the state of regulation in Japan, which is one of the three poles in a major drug-consuming country.
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