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, chemical drugs, biological products and traditional Chinese medicine/natural herbal drugs are regulated by the National Medical Product Administration (NMPA), which is a counterpart of the US FDA. The Center for Drug Evaluation is responsible for the technical review and evaluation on the submitted applications.

 

There 5 types of drug application in China: 
1.   New drug application

2.   Generic drug application

3.   Import drug application

4.   Supplemental application

5.   License renewal

For oversea manufacturers, 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, the NMPA 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 Filings 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. Within 1-2 weeks of submitting the filing dossier, the Center of Drug Evaluation (CDE) will release the DMF number on its official website. The initial status of the DMF filings will be inactive (status of "I"), and once it passes the review and evaluation through bindingly review with the finished drug formula, the status of the DMF filings will be switched to active (status of "A"). 

 

 

 After DMF Filings

The DMF holder is required to submit an annual update, at the first quarter of every calendar year, to the CDE.

In case, there is any change to the filed information, the DMF holders owe the responsibility and obligation to notify the manufacturer of finished formula immediately. The DMF holders should take the initiaitve to investigate/study the potential impact, of change, on product quality.

When a manufacturers of finished drug formula uses the filed product in the drug formula, all the DMF holders need to do is to issue a Letter of Authorization to the manufacturers of finished drug formula, so as to refer to the filed dossier for bindingly review.

 


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