China proposes changes to drug trial and API importation laws

By Gareth Macdonald contact

- Last updated on GMT

iStock/liulolo
iStock/liulolo

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The proposed changes – outlined in a draft guidance document issued by the China Food and Drug Administration (CFDA) on March 17 (here​ in Mandarin) – are designed to meet shorten clinical trial and approval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

Related news

Show more

Related products

show more

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Innovations in OSD

Innovations in OSD

Recorded the 06-Oct-2020 | Webinar

This DFE series of educational webinars looks at innovations in Oral Solid Dose Forms with the emergence of advanced technologies such as Continuous Manufacturing...

Lactium, your ally to manage day to day stress

Lactium, your ally to manage day to day stress

Ingredia | 27-Aug-2020 | Product Presentation

Stress has been called the ‘health epidemic of the 21st century’ by the World Health Organization. Increasingly, consumers are looking for safe, reliable...

Related suppliers

Follow us

Products

View more

Webinars