Notice on Printing and Distributing Regulations for the Registration of Pharmaceutical Technology Transfers

National Food and Drug Administration Note [2009] No. 518 released on August 19, 2009

Food and Drug Administration of the provinces, autonomous regions, and municipalities directly under the Central Government (Drug Surveillance Administration), and the Drug Administration of the Ministry of Health of the General Logistics Department:

In order to standardize the registration of drug technology transfer and ensure the safety, effectiveness, and quality of drugs, according to the relevant provisions of the "Measures for the Administration of Registration of Drugs," the SIPO has organized the "Administrative Regulations for the Registration of Drug Technology Transfers" (hereinafter referred to as the "Regulations"). Is now issued, please follow the implementation.

As the new drug monitoring period was established on December 1, 2002, according to the original "Administrative Measures for Registration of Drugs (Trial)", before that, according to the original "Protection of New Drugs and Technology Transfer Regulations" (1999 Decree No. 4) and "About The “Notice of the Protection Period for New Drugs that Have Approved Production and Clinical Research before the Implementation of the Regulations of the People’s Republic of China on Drug Administration Law” (SINOPHARM INSTRUCTIONS No. 59, 2003) defines the concept of protection period and transition period of new drugs. In order to ensure the smooth transition and convergence of the old and new laws and regulations, the following issues shall be implemented for such matters relating to the transfer of technology with protection period and transitional period:

I. For varieties that have the New Drug Certificate and are still in the new drug protection period, refer to the requirements in the "Regulations" for the transfer of new drug technology;

2. For the varieties that have the “New Drug Certificate” and the new drug has expired, refer to the requirements for the transfer of drug production technology in the “Regulations”;

3. For the varieties that have the "New Drug Certificate" and are still in the transition period, refer to the requirements for the transfer of new drug technology in the "Regulations";

Fourth, for the varieties that have the "New Drug Certificate" and the transition period has expired, refer to the requirements for the transfer of pharmaceutical production technology in the "Regulations";

The "Regulations" shall be implemented as of the date of promulgation, and the original provisions for the transfer of relevant drug technologies will be abolished at the same time.


State Food and Drug Administration August 19, 2009

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