The CFDA has issued new policies to reduce the very long waiting times for approvals -- both for clinical trial and marketing approvals. According to a recent Ropes & Gray internet posting (see article), the new rules: 1) expand the categories of new drugs that qualify for fast-track approval; 2) simplify the clinical trial approval procedure; 3) allow innovative companies to file for approval without owning their own drug manufacturing facility; and 4) classify drugs that are approved outside of China as generics for China approval.

1). Expand the categories of new drugs that qualify for fast-track approval

Previously, the fast track "green channel" approval pathway was open only to drugs that weren't marketed anywhere in the world, or those addressing critical or unmet medical needs. Now the CFDA will allow categories of drugs addressing additional categories, including:

• pediatric/geriatric drugs,
• drugs treating China-prevalent diseases,
• drugs sponsored by national science and technology grants,
• foreign innovative drugs that will be manufactured locally in China,
• innovative drugs using advanced technology, innovative treatment methods, or with distinctive clinical benefits, and
• drugs manufactured at a US/EU qualified facility and under review by the USFDA/EMEA for concurrent marketing authorizations.

Requests for clinical trial authorization will be considered as long as the patent has three years of validity left; requests for marketing authorization will be considered if the patent has one year to go before expiring.

2) Simplify the approval process for clinical trials

Starting on December 1, 2015, the CFDA's clinical trial approvals will mean the drug is cleared for all phases of the process. Presently, each phase must be approved following the successful conclusion of the previous phase. For generic drugs, only a bioequivalence study will be needed for a recording filing with the CFDA. The applicant must also obtain an EC approval and sign a clinical study agreement with the clinical site prior to filing the bioequivalent study.

If this is done correctly, the CFDA will record the bioequivalent study in its database and issue a filing number automatically. The number allows the applicant to proceed with the trial.

If there are any changes to the original bioequivalency study, the applicant must suspend the original study, enter the changes in the online recording platform to obtain a new filing number, and then re-launch the study. 

3). Allow Entities without Manufacturing Facilities to Apply for Approvals

Currently, only drug manufacturers can ask for approval of their innovative drugs. This policy hurts small innovative companies (and research institutions) that do not have their own manufacturing facilities. Under the new regulations, a pilot program in ten provinces will allow China drug manufacturers, China R&D institutions, and research personnel of Chinese nationality to seek marketing approval of drugs that are produced by CMOs. However, to protect consumers in the case of a potential product liability, the company/institution must have either insurance or produce a financial guarantee to cover liability costs.

Change the classifications for new drugs and generics

Under the new rules, novel drugs are products that have never been marketed anywhere in the world, or those that represent improved forms of the new drugs. Previously, a drug that was approved outside of China (but not domestically) was considered novel if it filed for China approval. Now, generics must prove they are consistent with the reference drugs (or originator drugs) in terms of quality and efficacy. A significant upshot of the change is that pharmaceutical products previously marketed outside China will be considered a generic for China approval. 

These new mandates will have some far-reaching effects, making the approval process easier for certain categories of drugs, such as drug that now qualify for fast-track approvals or drugs that are approved outside of China. The CFDA still has to find enough evaluators to examine filings and reduce the agency's backlog of over-20,000 filings.

Disclosure: none.