Drug Delivery Technology

EMEA (European Medicines Agency). Because permission will be granted accepting the approvals of the protocols from these countries, the CDSCO estimates that approval time for clinical trials will take 2 to 4 weeks. However, all other applicants will fall under Category B, which will require protocol verification and take 3 to 4 months approval time.

The CDSCO ( http://cdsco.nic.in/ index.html) has also categorized protocol amendments into three groups: those not requiring any notification or permission, those that require notification but no permission, and those requiring prior permission from the CDSCO before implementation of clinical trial protocol amendments.

China: The State Food and Drug
Administration (SFDA;
www.sfda.gov/cn/eng/) is the Chinese
equivalent of the US FDA and is the
national authority that approves and
reviews clinical research. The regulation
of drugs and clinical trials is outlined by
the Drug Administration Law of the
People’s Republic of China, which went
into effect in December 2001, and the
Drug Registration Regulation of 2002.
Before a clinical trial may be carried
out in China, it must first be approved by
the SFDA. The sponsor should prepare
and submit the dossier and drug samples
to the SFDA, which will consult with the
Center for Drug Evaluation before
issuing a clinical trial approval letter.
Other drug institutes, such as the
National Institute for the Control of
Pharmaceutical and Biological Products,
will also aide the SFDA in screening
applications. The entire process for
clinical trial approval takes
approximately 7 to 9 months. Fast-track
₇₆review is available for clinical trials of

CIALTY PHARMA MARCH 2007 Vol 7 No 3

drugs that treat serious or life-threatening
illness, or for drugs that are the same
kind of drug as one that has already been
approved.

Southeast Asia: Each country has a specific governmental health organization that oversees clinical trials and pharmaceutical regulations. Approval processes can be relatively quick in these countries, taking only 3 to 4 months. The most popular location for clinical trials in Southeast Asia (not including Singapore) is Malaysia for its relatively developed hospital infrastructure and advanced regulatory environment for drugs.

Summary

Outsourcing clinical trials in Asia provides a way for US and European medical companies to reduce cost and increase productivity and efficiency. Currently, about 25% of US medical companies outsource overseas to some extent. Although IP protection issues still linger, some US companies are now outsourcing all phases of product development, including drug discovery, research and development, clinical trials, and manufacturing. American companies will continue to outsource in Asia as the medical communities in Asian countries continue to become more sophisticated and cost reduction can be more clearly defined.

To purchase Pacific Bridge Medical’s complete report on clinical trials/contract research organizations in Asia, please visit our website at www.pacificbridgemedical.com.

Mr. Ames Gross,
MBA
President & Founder
Pacific Bridge Medical

Mr. Ames Gross is President and Founder of Pacific Bridge Medical (PBM), and is recognized nationally and internationally as a leader in the Asian medical markets. Established in 1988, PBM is a consulting firm that assists medical companies with business development and regulatory issues in Asia. PBM has helped more than 200 medical companies over the years. Mr. Gross earned his BA, Phi Beta Kappa, from the University of Pennsylvania and his MBA from Columbia University.