Drug Registration


PHDS in the Drug Registration

PHDS has experts with over 20 years’ experiences in drug registration affairs in China. Up to date, PHDS has had successful and long-term cooperation with clients spread over 54 countries. And PHDS are trusted by many giants in pharmaceutical industries for over 500 cases’ experience, problem solving and professional competence. PHDS requests all employees must always conduct in accordance with SOP and Ethics of Employees.PHDS gets your products into China faster.


What we do:

1.     IDL registration gap analysis: To provide a critical appraisal for application dossiers and gap analysis for successful registration.

2.     Registration problem solving: We offer a fast and cost effective solution for deficient fundamental researches.

3.     Professional & clear documents compiling: We screen positive and supportive documents and skillfully compile a professional and mind clear application documents.


Why choose us:

1.     Well trusted by many giants in pharmaceutical industry;

2.     Recommended in annual Year Book by Chinese authority;

3.     Very experienced regulatory team;

4.     Proven track records with unquestioned reliability.


Drug Registration in China

In China, drug and biological products are regulated by the CFDA, which is a counterpart of the US FDA. The Center for Drug Evaluation regulates both drug and biological products in China. There are two drug registration pathways in China which include new drug application and import drug license. Similarly, there are two clinical development strategies. They are sequential development and parallel development.

Marketing authorization of a new drug in China mandates clinical trials with Chinese patients as prerequisite. The applicant has to conduct phase I pharmacokinetic studies together with randomized clinical trial with at least 100 pairs of subjects. Since 2017, CFDA launched new procedure for CTA, the time for CTA has been shortened significantly. Drug import approval requires availability of marketing authorization outside China, such as certificate of pharmaceutical product from a reference country. Multi-region clinical trials can be started only after the new chemical entity has been tested in phase II outside of China. This prevents China from participating in simultaneous global drug development. Drug approval in China follows first international new drug application approval (NDA). 


DMF Application in China

Since end of 2017, the NMPA (formerly CFDA) launched the DMF system for APIs, excipients and pharmaceutical packaging materials. The manufacturers of APIs, excipients and packaging materials do not need to conduct sample testings any more in China. Once the product is registered, the Center of Drug Evaluation (CDE) will release the DMF number of your products on its official website. Potential customers could find it by themselves. Then the manufacturers can authorize the pharmaceuticals to use the DMF in their application.


Contact us immediately
For more information, please call us on +86-10-84466227 or send us an email at: customer@cnphds.com