China proposes changes to drug trial and API importation laws

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Small molecule drugs, Clinical trial

Chinese regulators have proposed changes to rules covering clinical trials, API importation and drug approval in a bid to improve access to medicines.

The proposed changes – outlined in a draft guidance document issued by the China Food and Drug Administration (CFDA) on March 17 (here​ in Mandarin) – are designed to meet shorten clinical trial and approval times to meet “public demand for new drugs​.”

At present drugs can only be tested in China must if they have already gone through late stage studies (Phase II or III) or have been approved elsewhere. The new guidance would remove this requirement, enabling Chinese sites to be included in multi-centre studies.

Another proposal would allow foreign drug manufacturers with operations in China to import small molecule drugs and biologics before the product has been approved. Currently, imported drugs need to be approved in at least one market.

The CFDA also suggested drug firm’s whose multi-centre trials include a Chinese site should be allowed seek approval as soon as the study is completed.

The agency also said it plans to simplify registration rules for drugs that have been examined in multi-centre trials and waive trial registration requirements for subsequent China-based studies of such products.

The CFDA called for feedback on the proposed rule changes.

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