united-states international medical
If pharmaceutical manufacturing meets US CFR 21, or its European equivalent is it automatically accepted by all other countries?
<p>If pharmaceutical manufacturing meets US CFR 21, or its European equivalent is it automatically accepted by all other countries?</p>
<p>Do other countries automatically accept any other countries manufacturing standards if they are more stringent?</p>

<blockquote>
<p>If pharmaceutical manufacturing meets US CFR 21, or its European equivalent is it automatically accepted by all other countries?</p>
<p>Do other countries automatically accept any other countries manufacturing standards if they are more stringent?</p>
</blockquote>
<p>There may be countries that do this, but certainly not <em>all</em> countries do it, to address the question in the first paragraph.</p>
<p>The European Union, for example, has several <a href="https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra" rel="nofollow noreferrer">mutual recognition agreements</a> in place with several countries that have comparably strict manufacturing standards in place (Australia,
Canada,
Israel,
Japan,
New Zealand,
Switzerland, and the
United States).</p>
<p>From <a href="https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice" rel="nofollow noreferrer">https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice</a>:</p>
<blockquote>
<p>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.</p>
</blockquote>
<p>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.</p>
