HONG KONG – In a move to further improve regulations in the pharmaceutical sector, the CFDA recently established the China-Denmark Food and Drug Regulatory Cooperation Centre.

"The platform for information sharing will help the industry adapt to the trend of globalization of the food and drug supply chain, keep up with the pace of technological innovation in the food and pharmaceutical industry, seize the opportunity and work together for the exchange of food and drug regulatory technology," said Bi Jingquan, minister of the CFDA, speaking during the opening ceremony of the new center.

The ceremony was held recently at the new site of the National Institutes for Food and Drug Control. More than 100 industry professionals and representatives from the CFDA and government departments of Denmark attended, including both Chinese Premier Li Keqiang and Danish Prime Minister Lars Løkke Rasmussen. The CFDA and the Ministry of Environment and Food of the Kingdom of Denmark and the Ministry of Health of the Kingdom of Denmark earlier this month signed a memorandum of understanding to establish the center.

Bi said its opening "marks a new stage of cooperation in the field of food and drug regulation," while Esben Lunde Larsen, Danish minister of environment and food, spoke highly of the Chinese government's emphasis on food and drug safety and expressed appreciation for the effectiveness of the reform of the drug review and approval system.

Bi added that cooperating with Denmark will further improve China's food and drug regulatory system.

"We can learn from Denmark in the implementation of food and drug safety standards, corporate responsibility, product traceability, laboratory testing and the recall system, among other areas," said Bi, in comments distributed through a Chinese-language release.

"We do see the CFDA having a more open attitude and is very much willing to learn from international experiences," Helen Chen, managing director and partner at global strategy consulting firm L.E.K. Consulting, told BioWorld Today. "The March 17 draft notice to support the much closer timing of the Chinese approvals to their international first approval timelines is one of the recent example."

The March draft notice on Adjusting Registration of Imported Drugs noted that investigational drugs, except for vaccines, will no longer require approvals from another country or to undergo phase II or phase III trials elsewhere before an international multicenter trial (IMCT) can be conducted in China.

In addition, for foreign drugs that have completed an IMCT in China, companies can apply directly to the CFDA for a new drug application (NDA). Foreign manufacturers can also apply for import registration of innovative chemical drugs or biologics before the drug has been approved in its home country or region.

"The CFDA is also exploring their participation in the ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use], among others, and often has exchanges with other countries' regulatory agencies," said Chen.

Founded in 1990, the ICH is an international pharmaceutical industry alliance of regulatory authorities and the pharmaceutical industry with a focus on the scientific and technical aspects of drug registration. The ICH aims to achieve greater harmonization of regulatory requirements worldwide to ensure that high quality medicines are developed and registered efficiently.

The ICH's "concerns over rising costs of health care, escalation of the cost of R&D and the need to meet the public expectation that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need" is in line with China's efforts to shorten drug approval times and to improve drug accessibility.

Recently, the CFDA released a policy draft, titled "A Policy that Encourages Clinical Trial Management Reform for Drug and Medical Device (Draft)," in which the agency officially recognizes overseas bioequivalence (BE) data for drugs that have been approved to market by the U.S. FDA, EMA and Japan's PMDA. Those drugs are eligible for an NDA in China after onsite inspection by the CFDA. "This will significantly shorten new drug launches in China with overseas registration," said Jefferies LLC in a recent report on the policy draft.