Flexibility [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2013-09-04 12:20 (4677 d 13:13 ago) – Posting: # 11429
Views: 11,805

Hi Helmut,
The European generic industry looks for legal certainty and does not like "flexibility". They want to stick to fixed and transparent rules in order to evaluate the risks and to assess the efforts and time to spend for a certain project. What you call "flexibility" is the reason why companies refrain from conducting studies in Russia. You could translate flexibility also by discretion, intransparancy and helplessness.
Russia is a very big and interesting market. Guess why so few generic companies try to enter this market.
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
140 visitors (0 registered, 140 guests [including 16 identified bots]).
Forum time: 01:34 CEST (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5