PHDS in the Drug Registration
PHDS has more than 20 years of experience in drug registration affairs in China, and maintains a long-term successful cooperative relationship with customers in 54 countries/regions. Trusted by many giants in the pharmaceutical industry, PHDS is distinguished by its rich case experience, problem-solving capabilities and professional capabilities. PHDS is your trusted partner, which can get your products into China faster. PHDS requires all employees to act in accordance with the SOP and the Code of Ethics at all times.
What we do:
1. GAP ANALYSIS FOR IDL REGISTRATION
To provide a critical appraisal for application dossiers and gap analysis for successful registration.
2. PROBLEM SOLVING FOR SUCCESSFUL REGISTRATION
To offer a fast and cost effective solution for deficient fundamental researches.
3. PROFESSIONAL & CLEAR COMPILATION FOR SUBMISSION
To screen positive and supportive documents and skillfully compile a professional and mind clear registration dossier..
4. GMP AUDIT & ON-SITE INSPECTION
To make GMP training and on-site inspection to the manufacturing site, especially to the oversea plants.
Why choose us:
1. Well trusted by many giants in pharmaceutical industry;
2. Recommended in annual Year Book of Chinese regulatory authority;
3. Professional & sophisticated 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 classifications of drug application in China:
1. INNOVATIVE DRUGS
2. IMPROVED NEW DRUGS
3. DOMESTIC GENERIC DRUGS (whose original dug has not been approved in China)
4. DOMESTIC GENERIC DRUGS (whose original dug has been approved in China)
5. IMPORT DRUGS
For oversea manufacturers, there are mainly two drug registration pathways in China which include innovative drug/improved new drug registration and import drug registration. 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, but the oversea clinical data can be bridged to China. Otherwise, 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 the application for clinical trial the approval time for clinical trial has been shortened significantly.
To appl for the registration of IMPORT DRUGS, the marketing authorization obtained in its country of origin is required, such as Certificate of Pharmaceutical Product (CPP). During the drug registration procedure, sample testing and/or on-site GMP inspection may be required, in parallel, upon NMPA/CDE risk assessment.
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 manufacturer of finished drug formula uses the filed product in the drug formula, the DMF holder of the filed product needs to issue a Letter of Authorization to the manufacturer of finished drug formula, so as to refer to the filed dossier for bindingly review in drug registraion.
Contact us immediately
For more information, please call us on +86-10-84466227 or send us an email at: customer@cnphds.com