【讨论】FDA Secure Supply Chain Pilot Program: 13 companies prequalified

zhulikou431

In August 2013, the U.S. Food and Drug Administration (FDA) initiated the so called Secure Supply Chain Pilot Program (SSCPP) to enhance the security of imported drugs.
The goal was to enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products into the United States.
With this program, FDA wants to better focus its imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.
The SSCPP is a voluntary program. Each firm accepted to participate in the program will be allowed to have up to five drugs subject to expedited import entry review. The SSCPP will be jointly administered by FDA's Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA).
Currently, the following companies have been accepted into the program:
AbbVie Inc.
Allergan, Inc.
Astellas U.S. Technologies, Inc.
Bristol-Myers Squibb Company
Celgene Corporation
GE Healthcare Inc.
GlaxoSmithKline LLC
Merck Sharp & Dohme Corporation
Mylan Pharmaceuticals Inc.
Novartis Pharmaceuticals Corporation
Pfizer, Inc.
Teva Pharmaceutcials USA, Inc.
Watson Laboratories, Inc.
Source: FDA press release

zjlshsh

提高进口药品的安全性没有错误，只是门槛提高而已。