Policy interpretation of the Pilot Program for drug listing license holders

positive significance of carrying out the pilot drug market licensing system?
The drug market license holder system is a common practice in the field of drug supervision in developed countries and regions such as Europe, the United States and Japan, which adopts the management mode of separating drug listing license from production license, and allows drug market license holders (holders of drug listing license documents, i.e. pharmaceutical production enterprises, research and development institutions or researchers) to produce their own medicines, or entrust other production enterprises to produce drugs.
At present, China implements a management model of the one-size-fits-all market license and production license for domestically produced drugs, allowing only pharmaceutical manufacturers to produce the drug after obtaining the drug approval number and being certified by the drug production quality management standard. In practice, drug research and development institutions and researchers can not obtain drug approval number, new drug research and development institutions to obtain a new drug certificate, can only transfer the relevant drug technology to drug manufacturers. This model of "bundling" drug registration and production license is not conducive to encouraging innovation, guaranteeing drug supply, and curbing low-level duplication of construction. It is of great significance to carry out the pilot work of drug market license holder system to encourage drug innovation and improve drug quality.
August 2015, the State Council issued the Opinions on Reforming the System of Review and Approval of Pharmaceutical Medical Devices (Guofa (2015) No. 44, referred to as State Council Document No. 44), proposing to carry out a pilot system for listing license holders. To carry out the pilot work is conducive to drug research and development institutions and scientific research personnel to actively create new drugs; It is conducive to industrial structure adjustment and optimal allocation of resources, promote professional division of labor, improve industrial concentration, avoid duplication of investment and construction.
, the legal basis of the pilot work?
On November 4, 2015, the 17th session of the Standing Committee of the 12th National People's Congress deliberated and adopted the Decision on Authorizing the State Council to Carry out the Pilot and Related Issues of the Drug Listing Permit Holder System in Some Places (hereinafter referred to as the Decision), authorizing the State Council to carry out the pilot drug listing license holder system, allowing drug research and development institutions and researchers to obtain drug approval numbers and assume corresponding responsibility for the quality of the drugs.
, the scope of the pilot area is what, how to determine the specific?
pilot areas are Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, Sichuan, ten provinces and municipalities directly under the Central Government. According to the newly amended Legislative Law on the authorization of specific matters, the pilot system for drug market licensing holders should be limited to some regions. After careful study, taking into account the distribution of drug industry development, free trade test zone, Beijing-Tianjin-Hebei coordinated development and the number of drug registration applications in China in the past three years and other factors, the pilot area will be designated as the above-mentioned ten provinces, municipalities directly under the Central Government.
, how is the scope of the pilot drugs stipulated?
scope of the pilot drugs mainly includes new drugs approved for market after the implementation of the pilot program, generic drugs approved according to the new standards, and some drugs approved for market before the implementation of the pilot program. Excludes narcotic drugs, psychotic drugs, toxic drugs for medical use, radioactive drugs, biological products for preventive use, and blood products.
the implementation period of the "Pilot Program for drug market licensing" is set?
"Pilot Program for Drug Listing Permit Holders" (hereinafter referred to as the "Pilot Program") will be implemented from the date of issuance until 4 November 2018.
, the drug market licensing system pilot and the current management system of the main difference?
The main difference between the pilot system of listed license holders and the current management system is that research and development institutions and researchers are allowed to hold drug approval numbers, become drug market license holders, and take full responsibility for the safety, effectiveness and quality control of the drug.
, what are the conditions for drug market license holders?
drug market license holders shall be pharmaceutical research and development institutions established in accordance with the law in the pilot area and capable of independent responsibility, or scientific researchers with Chinese nationality working in the pilot area. Drug production enterprises in the pilot administrative area shall be implemented in accordance with the relevant provisions of the holders of the Pilot Programme.
and responsibilities of drug market licensing holders?
Fulfill the corresponding obligations of the drug registration applicants and pharmaceutical production enterprises in the registration, production, circulation, monitoring and evaluation of drugs as stipulated in the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) and other laws and regulations, and bear corresponding legal responsibilities, including signing written contracts and quality agreements with the entrusted production enterprises, selling drugs in accordance with the relevant laws and regulations of the State on drug circulation, etc., or entrusting other enterprises that meet the qualification requirements to sell on behalf of, set up websites to actively disclose drug information, and fulfill the obligation to pay compensation for personal injury caused by listed drugs.
, what are the requirements for the actual production of drugs by the entrusted production enterprises?
The entrusted production enterprises that actually produce drugs shall be established in accordance with the law in the pilot area, and the pharmaceutical production enterprises holding the "Drug Production License" and the "Drug Production Quality Management Code" (hereinafter referred to as the "Drug GMP") certification certificate for the corresponding drug production scope.
, what are the obligations and responsibilities of the entrusted production enterprises?
the entrusted production enterprises shall fulfill the obligations of the relevant pharmaceutical production enterprises in the production of drugs as stipulated in the Drug Administration Law and other regulations, and shall bear corresponding legal responsibilities. In addition, we should fulfill the relevant obligations agreed with the holder in accordance with the law, and bear the corresponding legal responsibilities.
the provincial drug supervision and administration department where the holder is located carry out the supervision work when the entrusted production enterprise crosses the administrative area of the pilot province (city)?
The provincial drug supervision and administration department where the holder is located shall be responsible for supervising and managing the supervision and management of the holder and the approved listed drugs, and supervising the performance of the obligations of the holder to ensure product quality, entrusted production management, listed sales and services, adverse reaction monitoring, product recall, post-market evaluation, etc. Where a entrusted production enterprise crosses the administrative area of the pilot province or city, the provincial drug supervision and administration department where the holder is located shall jointly carry out extended supervision by the provincial drug supervision and administration department where the entrusted production enterprise is located, supervise the listed license holder to perform his duties in place and carry out the responsibilities, and urge the entrusted production enterprise to strictly manage and standardize production. The provincial regulatory department where the entrusted production enterprise is located shall be responsible for the day-to-day supervision of the relevant enterprises and urge the relevant enterprises to continue to complie. The provincial drug supervision and administration department where the holder is located and the provincial drug supervision and administration department where the entrusted production enterprise is located shall work together to ensure that the regulatory tasks are put in place by strengthening the interface and coordination.
specific requirements for investigating and prosecuting illegal acts of pilot drugs?
the holders and entrusted production enterprises that violate laws and regulations such as the Drug Administration Law and the relevant provisions of the Pilot Program shall be investigated and punished in accordance with the law by the provincial drug supervision and administration departments where they are located.
if a drug quality and safety violation causes a safety hazard, the provincial drug supervision and administration department shall take emergency risk control measures on the relevant products and organize a case investigation and prosecution in accordance with the law to hold the holder and the person directly responsible accountable.
the provincial drug supervision and administration department where the holder is located shall hold the holder (or the entrusted production enterprise) accountable for any violations in the pharmaceutical production process.
the effectiveness of the drug approval number issued during the pilot work?
drug approval number issued during the pilot work, after the end of the pilot period, will continue to be valid for the period of validity as set out in the drug approval document.
14th, after the end of the pilot work, what corresponding work measures?
After the conclusion of the pilot work, the General Administration of Food and Drug Administration will sum up the pilot experience in a timely manner, put forward proposals for amending and perfecting laws and regulations such as the Drug Administration Law and the Regulations on the Implementation of the Drug Administration Law, and revise and improve the relevant departmental regulations in order to fully implement the drug market licensing system for all drug varieties nationwide in due course. (State Administration of Drug Administration)