About RAs: |
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Is there laboratory with legal competence to test the medicinal products introduced on the market? |
Yes |
Yes |
Yes |
Yes |
Yes |
Does RA have its own laboratory structure? |
No |
No |
Yes |
Yes |
Yes |
Post-marketing quality control testing programs for medicinal products. |
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Is there institutional post-market sampling and testing programs for medicinal products? |
No |
Yes |
Yes |
Yes |
Yes |
Is it a periodic sampling and testing program? |
No |
Yes |
Yes |
Yes |
Yes |
Are there analytics data that demonstrate the continuity of the program? |
No |
Yes |
Yes |
Yes |
Yes |
Does the program have defined criteria for product selection? |
Yes |
Yes |
Yes |
Yes |
Yes |
Are there public guidelines that describe the procedure for sampling and testing of medicinal products? |
Yes |
Yes |
Yes |
Yes |
Yes |
Are the pharmacopeial specifications adopted as first quality standard on the samples tested? |
Yes |
No |
No |
Yes |
Yes |
Are the regulatory specifications (approved specifications and methods) adopted as first quality standard on the samples tested? |
No |
No |
Yes |
No |
No |
Are the official medicines control laboratories in-house methods adopted as first quality standard on the samples tested? |
No |
Yes |
No |
No |
No |
When a doubtful, aberrant, or suspected result (OOS result) is identified, are the samples retested using the approved method for marketing authorization? |
Yes |
Yes |
Yes |
Yes |
Yes |
About pharmacopeias: |
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Is there own national pharmacopeia? |
Yes |
N/A |
Yes |
No |
Yes |
Nationally, in addition to the national pharmacopeia, if any, are other foreign pharmacopeias recognized by RA? |
Yes |
N/A |
No |
Yes |
No |
If RA recognizes foreign pharmacopeias, is it allowed to adopt as an alternative to the specified in the national pharmacopeia? |
No |
N/A |
N/A |
N/A |
N/A |
Is it allowed to adopt foreign pharmacopeias as complementary tools to the national/ regional pharmacopeia? |
Yes |
N/A |
U |
N/A |
Yes |
If the monograph is not specified in the national pharmacopeia, if any, are there criteria, system, or organization in which non-national pharmacopeias are relevance-ranked? |
No |
N/A |
N/A |
No |
N/A |
Is there own regional pharmacopeia? |
No |
Yes |
Yes |
No |
No |
If RA recognizes regional pharmacopeias, is it adopted instead of the national pharmacopeia (if any) even if the monograph is specified in the national pharmacopeia? |
N/A |
Yes |
Yes |
N/A |
N/A |
Is it allowed to adopt national pharmacopeias as complementary tools to regional pharmacopeia? |
N/A |
N/A |
Yes |
N/A |
N/A |
Are there institutionalized procedures by RA that promote convergence between regulatory and official specification, which minimizes divergence between them? |
No |
Yes |
Yes |
N/A |
Yes |
Quality specifications |
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Do the guidelines express the purpose and distinction between method and specification approved in the marketing authorization application, in-house release specifications and pharmacopeia specification? |
No |
Yes |
Yes |
No |
Yes |
Do the marketing authorization procedures prevent or hamper the adoption of wider ranges for acceptance criteria or tolerance limits, the inferior performance of the analytical procedure and less selective analytical techniques than those of that pharmacopeia adopted in the country? |
No |
Yes |
Yes |
Yes |
Yes |
Do the guidelines express clearly that requirements of the pharmacopeia monograph are mandatory for all medicinal products / Meet the pharmacopeial specifications are required in the sampling testing programs? |
No |
Yes |
Yes |
N/A |
Yes |
Do the guidelines express clearly that in case of dispute, regarding the OOS results, the pharmacopeial text, shall prevail? |
No |
Yes |
Yes |
N/A |
Yes |