As patent drugs come due, generic drugs and their fringe products will become more and more popular. Therefore, the guide and specification for the industry development become increasingly significant. However, there is a certain market confusion of the examination and approval for fringe products of generic drugs because of relevant policies changes. Anyway, the development of generic drugs and their fringe products are irresistible.
Law enforcement confusion due to separation of power and responsibility of the subject: on one hand, partial products are out of the regulatory scope. Pre-licensing is not required for the management of the marginal products of generic drugs which is liable to cause the situation of "many can take in charge of the management, but many are not willing to take in charge". On the other hand, the power and responsibility of the subject for regulation are separated. Generally, the fringe products of generic drugs in our country are together supervised by many departments and those departments are difficult to work together because of their respective laws.
Supervision loopholes caused by unbalance of doctrine of liability fixation: the forces of supervision on fringe products of generic drugs carried out in each place are scattered because of the diversified targets. The cases handed over to the drug supervision department by other departments in the supervision of each place are very few; the supervision of the fringe products of generic drugs is still conducted by single departments (they are fighting alone).
The development of generic drugs and their fringe products are inevitably irresistible, therefore, the specification issue for them is extremely urgent and relevant departments must clearly separate their power and responsibility to solve the law enforcement confusion and block the supervision loopholes of the industry, making it developing in a smooth and healthy way.
(April 04, 2014 From CPhI.cn)