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If pharmaceutical manufacturing meets US CFR 21, or its European equivalent is it automatically accepted by all other countries?

Do other countries automatically accept any other countries manufacturing standards if they are more stringent?

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    US CFR 21 is the whole book of regulations that dictate how to file a drug application.
    – Trish
    May 24, 2023 at 18:26
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    How would one country determine if another countries rules are (1) more stringent, and (2) being followed without determining those?
    – Jon Custer
    May 24, 2023 at 18:44
  • Should we assume that the question concerns only substances that are approved in both countries?
    – phoog
    May 24, 2023 at 18:56
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    @Trish title 21 covers way more than just how to file a drug application. Some of it even has nothing to do with the pharmaceutical industry, being as it is "Food and Drugs."
    – phoog
    May 24, 2023 at 18:59

1 Answer 1

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If pharmaceutical manufacturing meets US CFR 21, or its European equivalent is it automatically accepted by all other countries?

Do other countries automatically accept any other countries manufacturing standards if they are more stringent?

There may be countries that do this, but certainly not all countries do it, to address the question in the first paragraph.

The European Union, for example, has several mutual recognition agreements in place with several countries that have comparably strict manufacturing standards in place (Australia, Canada, Israel, Japan, New Zealand, Switzerland, and the United States).

From https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice:

Manufacturing sites outside the EU are inspected by the national competent authority of the Member State where the EU importer is located, unless a mutual recognition agreement (MRA) is in place between the EU and the country concerned. If an MRA applies, the authorities mutually rely on each other's inspections.

It's easy to imagine that some of the countries that would rather accept the results of (for example) FDA inspections than inspect manufacturers themselves do not have the technical level required by the FDA to conclude a mutual recognition agreement. Such countries could unilaterally decide to honor the results of FDA inspections. Whether any countries actually do this, I do not know.

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