Updated on 23 May 2012
The government is keen on expansion of the national essential drug list (NEDL) this year to cover nearly all government-sponsored grass-root health institutions. This brings a strong opportunity for pharmaceutical companies, especially for the domestic firms. In July 2011, the MoH revealed that, as part of the country's universal health coverage program, it may introduce mandatory licensing policy to secure cheaper drugs for HIV/AIDS patients.
In March 2011, the World Health Organization (WHO) announced that the Chinese State Food and Drug Administration (SFDA) and its affiliated institutions meet WHO indicators for a functional vaccine regulatory system. Subsequently, in July 2011, WHO sanctioned SFDA to approve domestic vaccines for international use.
Chinese vaccine manufacturers' products can now obtain WHO prequalification in one-to-two years. The successful applicants can supply vaccines to the United Nation Children's Fund (Unicef), which will then distribute the products to developing countries. Receiving prequalification will help Chinese firms to rake in international deals.
After five years of amendments and two rounds of public consultations, the SFDA issued good manufacturing practice (GMP) for drugs, effective from March 1, 2011. As per the guideline, the newly built drug manufacturers and reconstructed or extended workshops of drug manufacturers shall comply with GMP requirements.
Improving the situation of existing facilities, the SFDA has instructed that the existing drug manufacturers will be granted a transition period of five years to meet stage-by-stage new version of GMP in accordance with the product risk level. The SFDA has also started to inspect overseas manufacturing facilities in November 2011, as the agency seeks to align its practices with international standards.