- Clinical trial approval certificate
- Marketing authorization certificate
- Re-registration certificate (for registration renewal)
- Supplemental application approval certificate
- Traditional Chinese medicine (TCM) protection certificate
- Imported raw ingredient certificate
- Certificate for active pharmaceutical ingredient (API) of chemical drug
- Good laboratory practice (GLP) certificate
Documents such as drug manufacturing process document, quality standard document, medication package insert, and label will not be included in electronic drug registration certificate itself. Instead, along with the electronic certificates, the attachments will be available in electronic form on the same online service platform mentioned above.
Compared to the paper version, which will still be in use, the electronic version of drug registration certificates can be faster accessed by the MAHs and drug applicants. Electronic files are also more convenient for MAHs and drug applicants to check the certificates by scanning codes, verify the certificates online, and authorize other parties to use the certificates.
[Reprinted from BaiPharm]Contact Us
With our experts across China, Japan, South Korea, the United States, and Europe, BaiPharm is fully qualified to engage in complex market entry projects of finished drugs, APIs, excipients, and packaging materials for most key markets. If you have any questions about pharmaceutical regulatory compliance in China, please feel free to contact us. Tel: +86 (0)571 8710 3829 Email: customer@reach24h.com
News Source: ChemLinked
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