The China Food and Drug Administration (CFDA) has been working on a revision to the country’s Drug Administration Law. A draft version could be submitted to China’s State Council by the end of 2014.
There are a variety of changes expected to be included in the new law, including:
- A Marketing Authorization Holder (MAH)
- Third party organization(s) to help the Center for Drug Evaluation (CDE) assess product dossiers
- A system to provide damage payments to patients who experience adverse reactions
- Priority review for new drugs and generics with great clinical value
- Delegated responsibility for product approval to provincial level FDAs
- Fewer investigative study requirements for imported drugs that have been approved in other countries, such as the U.S. and EU
- Enhanced post-marketing surveillance and enforcement responsibilities
Reducing the workload of the CDE is a key issue. The CDE has fewer than 200 drug reviewers — compared with approximately 3,500 at the U.S. FDA — and received more than 7,500 drug applications in 2013. This has led to delays of more than a year for new drug approvals and clinical trial authorizations in China.