Pharmaceuticals & APIs Registration

Pharmaceuticals (drug) registration means the legal process by which a decision is made to either approve or not approve the conducting of a drug clinical trial, production or importation of a drug to be marketed, based on a systematic evaluation of the safety, efficacy and quality control of the drug, including the approval process of an application to change any item on the approval certificate and its attachments.

The State Food and Drug Administration (SFDA) of China is the competent national authority for drug registration, which is responsible for the review and approval of clinical studies, production and importation of drugs.

Our Services

• Feasibility assessment
• Translation and documentation
• Project tracking
• Lab test arrangement

Application for Drug Registration

Includes:

• Application for new drug
• Application for a drug already with national standards
• Application for import drug
• Supplemental application
• Application for re-registration of drug

A local applicant shall be a legally registered institution in China.

A foreign applicant shall be a legally established pharmaceutical company. In making application for an import drug registration, the foreign applicant shall use its office in China, or authorize an agent in China to handle the application.

Flowchart for Health Food Registration

SFDA working flowchart:

Contact

Email:	chengwei@sinopharm.com
Tel:	+86-10-62026699 ext.1205
Fax:	+86-10-62032345

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