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rajasekharkakarla
Junior

India,
2018-10-06 08:05

Posting: # 19411
Views: 193
 

 Test License [Regulatives / Guidelines]

Dear All,

I applied Test license for some X drug in India, I got permission and I imported the drug (reference) from outside India then conducted one study (pilot). Now I want to conduct one more study (pivotal) with remaining quantity of Reference drug from first study. Here I have some doubts:

1) Can I use remaining quantity of reference drug for pivotal

2) If we use remaining IPs, Is we need to get Test license permission for pivotal.

or

Is we need to apply fresh Test license to import Reference drug separately for pivotal.

Please guide me to overcome this issue.

Regards,
RK
Obinoscopy
Regular

Nigeria,
2018-10-06 12:58

@ rajasekharkakarla
Posting: # 19412
Views: 175
 

 Test License

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.

Regards,

Scopy
wienui
Regular

Germany, Oman,
2018-10-07 21:04

@ rajasekharkakarla
Posting: # 19414
Views: 142
 

 Test License

Dear RK,

» I applied Test license for some X drug in India, I got permission and I imported the drug (reference) from outside India then conducted one study (pilot). Now I want to conduct one more study (pivotal) with remaining quantity of Reference drug from first study. Here I have some doubts:

» 1) Can I use remaining quantity of reference drug for pivotal
No, You can't use the rest of the reference drug for conducting a BE Study with a new ordered reference drug batch, as they are two different Batches ( Biobatches).

» 2) If we use remaining IPs, Is we need to get Test license permission for pivotal.

Yes, you will need.

Regards,

Osama
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