On the last day of April, a petition signed by more than 200 local and foreign pharmaceutical companies over the draft for the new "Provisions for Drug Registration" was sent to the SFDA.

"In general, many provisions in the draft are not well-defined, and it is ambiguous in some places", said Mr. Rui Guozhong, director of China Pharmaceutical Science & Technology Industrialization Center. Rui is the primary author of the petition.

Some of the major criticisms on the draft regulation are:

1. Pharmaceutical companies question the rationale for an extension of the approval time for generic drugs. The current regulation requires approval for generic drug applications to be completed within 80 working days, but the draft new regulation extends this to 160 days.

One expert who was involved in the the drafting of the new drug registration regulation explained that the SFDA intended to use the extended approval time to ensure more stringent evaluation and to build higher entry barrier for generic products. However, pharmaceutical companies dispute the use of lowered administrative efficiency as a means to restrain market entry for generic drugs. They also contended that longer approval time does not necessarily result in more stringent approvals, citing also that enterprises are often forced to offer briberies in order to boost administrative efficiency.

2. Excluding certain exceptions, the draft regulation restricts the registration of new dosage forms/specifications of a new drug by applicants other than the holder of the original new drug approval. The measure is desigend to reduce the number of drug registrations for new dosage forms and specifications. Companies argue that drug regulatory agencies should not intervene with the market, and the current problem of excessive number of such registration applications should be resolved by market forces, not by the government power.  In addition, companies also stated that the exceptions for this requirement are not well-defined, thus may lead to more problems.

3. There is also a requirement in the draft for SFDA to evaluate the market value and risk of a drug product before issuing its approval.  SFDA obviously intended to use this requirement to control the problem of having too many approvals and manufacturers for one drug product.  However, the petition challenges that the SFDA has no jurisdiction, authority and expertise to access the merits of the market value or risks of drug products and to approve them on any basis other than drug safety and efficacy. 

4. The latest draft of the new regulation also contains a provision that allows SFDA to designate parts of its drug evaluation work to qualified provincial food and drug administrations. Companies argue not only the provision is vaguely defined, but also the measure may become a problem in future for maintaining a national uniform standard in drug evaluation and approvals largely due to the presence of local protectionism. 

Meanwhile, it is believed that the draft for the appendices of the proposed new drug registration regulation was already completed by SFDA in late April. However, the SFDA has not announced the publication date for this draft so far.