The QMN Weekly Bulletin

China Pushes Pharma to Comply With Revised GMPs

Jan. 10, 2014

China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate.

The CFDA has published a notice warning that manufacturers who do not have a certificate will lose marketing privileges.

As of January 1, 796 manufacturers of sterile drugs in China have met the new GMP requirements, accounting for about 60 percent of the total number of manufacturers in the country, according to a CFDA notice.

Companies must apply for the certificate, mandated by regulatory changes in 2010, and satisfy the new GMP requirements or the CFDA intends to rescind their marketing privileges.

The regulator plans to have all drugmakers updated with the current GMP certificates, which were mandated by regulatory changes in 2010, before the end of the year.

Some of the changes in the updated GMP certificate include:

  • Establishing a clearer quality management system and creating more detailed organizational structure, including responsibilities, procedures and putting in place resources to implement the GMP activities;

  • Establishing specific qualifications when hiring GMP staff;

  • Instituting enhanced reporting and documenting procedures; and

  • Enhancing better storage and production facilities.

A spate of Chinese infant deaths in November related to GMP-certified hepatitis B vaccines has pushed the country’s health officials to review drug manufacturers more closely.

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