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 24 countries. And PHDS are trusted by many giants in pharmaceutical industries for over 300 cases’ experience, problem solving and professional competence. PHDS requests all employees must always conduct in accordance with SOP and Ethics of Employees.Choosing PHDS is to book a market share in advance for your products.

 

What we do:

1.     IDL registration pre-evaluation: To provide a pre-evaluation on application dossiers for potential customers.

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

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 record 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. Clinical trial application review and approval takes approximately 12 months. 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).