Test License [Regulatives / Guidelines]

posted by Obinoscopy  – USA, 2018-10-06 12:58 (1211 d 02:33 ago) – Posting: # 19412
Views: 1,532

Dear Rajasekharkakarla,

It depends on which NRA you intend seeking MAH from. If from outside India or if seeking PQP from WHO, then it doesn't matter as long as the reference product is on their list of approved comparator products/RLDs.

But if from India, then it depends on their guideline. What was the content of the Test License given you? Was it stated anywhere on that letter that the reference product being imported is for pilot studies only? What was the correspondence etween you and the India NRA? did you tell them that the reference product is intended for Pilot Studies only?

These are the things you have to consider.



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