Current issue #11, 2016

No one confessed of authoring draft amendments on cancelling API manufacture audits

PharmVestnik got hold of draft amendments to the Federal law FZ-61 “On Drug Circulation” that is allegedly being reviewed by a variety of executive bodies and is shortly to be considered by Dmitry Medvedev’s Cabinet. Having leaked into the industry, the document caused resentment among local API manufacturers despite the fact that its declared aim was creating “additional opportunities for drug manufacturers”.

[PharmVestnik # 11, 29/03/2016, p. 1, cont’d p. 5]

A stumbling term

Ministry of Health has given hostage to situation in common drug market

Over the three months after the launch of the common pharma market, drug manufacturers have been unable to receive comprehensive answers to questions relating to product registration in the common market. The MoH’s explanations have left the local manufacturers perplexed rather than satisfied. The regulators do not have other explanations to offer as the documents in respect of product registration have not been approved yet. Experts explain that the situation was created by the Federal Antimonopoly Service insisting that the notion of interchangeability be accepted by the common market. The MoH has given hostage to the situation, and there is little hope that it may be resolved soon.

[PharmVestnik # 11, 29/03/2016, p. 2]

One phase would be enough

Companies obligated to conduct clinical trials when registering drugs in Eurasian Economic Union (EEU)

Pharma companies continue their active preparations to operating in a common drug market within the EEU. As of today, basically all major underlying documents have been prepared. Notwithstanding the fact that the Regulations for Human Drug Registration and Assessment have not been approved yet, manufacturers may already start preparatory work. The thing is that the EEU member countries have failed to agree just on o...