4:05 PM
Mar 13, 2018
 |  BC Extra  |  Politics & Policy

China FDA overhaul could speed regulatory reforms

A major overhaul of China's ministries proposed by the State Council will create a State Drug Administration to oversee drug approvals and supervision. The change could focus regulators on implementing reforms aimed at raising China’s drug regulations to international standards because unlike China FDA, the new entity will not be responsible for food administration, according to Richard Yeh of Goldman Sachs.

The State Drug Administration will be part of a newly formed State Administration of Market Supervision, which will combine the responsibilities of CFDA and two other agencies.

Additionally, the State Council has proposed to consolidate administration of China's three national medical insurance plans under a new State Administration for Health Security division. The proposed consolidations "may potentially drive a more efficient and payer-oriented policy" and shift the prescription mix to drugs with proven clinical benefit, said Yeh.

All told, the State Council's Institutional Reform Plan will reduce ministerial-level entities by eight and vice-ministerial-level entities by seven in an effort "to make the government better structured, more efficient and service-oriented," according to government news agency Xinhua. The plan has been submitted to the 13th National People's Congress for final approval.

In the past year, CFDA has taken steps towards modernization in part to help bring more innovative medicine to the country.

In May, CFDA proposed a draft regulation to require that the agency acts on a clinical trial application within 60 days of a submission, otherwise a sponsor would be allowed to proceed with a trial. Under the current system, CTAs from foreign companies can take 18 months to gain CFDA's approval, and there is no deadline for a decision (see BioCentury, March 28, 2016 and BioCentury Extra, May 12, 2017).

The draft would also permit the use in NDAs of clinical trial data generated overseas, provided an on-site inspection has been completed and evidence is presented to show there are no clinical differences pertaining to racial groups. Multinational corporations would also be allowed to conduct Phase I studies in China, and submit NDAs directly based on international trial data.

In June, CFDA was approved as a regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). At the time, CFDA said joining ICH would allow China's regulators, industry and institutions to be able to both implement and develop international standards, guidelines and rules (see BioCentury Extra, June 20, 2017).

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