Medical Policies Weekly (Issue 19,2020)
1、The third batch of national centralized drug procurement was launched.
On July 29th, the state organized the release of the Medicine Centralized Procurement Document (No. GY-YD2019-1) by the Office for the Centralized Procurement and Usage of Drugs and launched the third batch of nationally organized centralized drug procurement and usage. A total of 56 varieties and 86 product specifications are involved in the centralized procurement, which will be in an open tender of Shanghai on August 20th.
According to the documentation requirements, the agreed purchase quantity of each variety of each place in the first year shall be determined according to the following rules: if the actual number of selected enterprises in China is 1, it will be 50% of base figure for calculation of the agreed purchase quantity in the first year; if the actual number of selected enterprises in China is 2, it will be 60% of base figure for calculation of agreed purchase amount in the first year; if the actual number of selected enterprises in China is 3, it will be 70% of base figure for calculation of agreed purchase amount in the first year; if the actual number of selected enterprises in China is 4 or more, it will be 80% of base figure for calculation of agreed purchase quantity in the first year.
Among others, agreed purchase quantity of each district in the first year of Amoxicillin granules, Linezolid oral regular release dosage form, Moxifloxacin hydrochloride sodium chloride injection, Levofloxacin eye drops, Ciprofloxacin oral regular release dosage form, Omnicef (Cefdinir) oral regular release dosage form, Cefaclor oral regular release dosage form and Clarithromycin oral regular release dosage form shall be determined according to the following rules: if the actual number of selected enterprises in China is 1, it will be 40% of base figure for calculation of the agreed purchase quantity in the first year; if the actual number of selected enterprises in China is 2, it will be 50% of base figure for calculation of agreed purchase amount in the first year; if the actual number of selected enterprises in China is 3, it will be 60% of base figure for calculation of agreed purchase amount in the first year; if the actual number of selected enterprises in China is 4 or more, it will be 70% of base figure for calculation of agreed purchase quantity in the first year.
As for the procurement cycle, if the actual number of selected enterprises in China is 1 or 2, the current procurement cycle of this round is in principle 1 year; if the actual number of selected enterprises in China is 3, the procurement cycle of this round is in principle 2 years; if there are 4 or more enterprises in China, the procurement cycle of this round is 3 years in principle. Among them, the procurement cycle of Azacytidine injection, Moxifloxacin hydrochloride sodium chloride injection and concentrated solution of Levetiracetam injection in this round is 1 year in principle.
2、The CDE issued Drug Evaluation Report 2019.
2、The CDE issued Drug Evaluation Report 2019.
On July 30th, the CDE issued Drug Evaluation Report 2019. In terms of the drug registration acceptance, in 2019, the CDE accepted 8,082 new registration applications (including 5 device combination products). Among them, 6,475 applications for chemical drug registration were accepted, accounting for about 80 percent of all applications accepted in 2019; there were 528 registration applications (244 varieties) for domestic class-1 innovative drugs, including 503 clinical applications (228 varieties) and 25 marketing applications (16 varieties). Indications for innovative drugs mainly focus on anti-tumor, anti-infection, digestive diseases and other fields; there were 157 registration applications (92 varieties) for class-5.1 imported Original Drug [1] of chemical drugs, and 172 applications (75 varieties) for class-1 imported innovative drugs. Indications for innovative drugs mainly focus on the fields of antitumor, endocrine and nervous system diseases.
In terms of evaluation, review and approval for drug registration applications, in 2019 a total of 8730 registration applications complete evaluation, review and approval (including instrument combination product 5 pieces). At the end of 2019, the number of registration applications under and awaiting evaluation, review and approval has dropped from a peak of nearly 22,000 in September of 2015 to 4,423 (excluding registration applications that have completed the audit and are waiting for the applicants to reply to the supplementary information due to defects in the declared materials), which consolidates the effects of reform in document no. 44, where the elimination of the backlog of registration applications is required. Among them, there are 926 IND applications, 164 NDA applications, 654 ANDA applications, 260 consistency evaluation applications for oral solid preparations (95 varieties in terms of the active ingredient statistics, 107 varieties in terms of the general name statistics) approved by the audit and ten innovative drugs of class 1 have been listed after the audit, 58 varieties of imported Original Drug after review (including new indications) approved by the audit, and 143 registration applications (82 varieties in terms of generic names) have passed the priority review procedures.
3、The CDE solicited several opinions on technical guidelines for clinical trials.
In order to implement the relevant requirements of Opinions of the State Council on Reform of the System of Evaluation, Review and Approval of Drugs and Medical Devices (Guo Fa [2015] No. 44), to encourage new drugs research and development and accelerate the construction of the technical guidance system for innovative antibacterial drug R&D and evaluation, the CDE issued four technical guidelines: Technical Guidelines for Clinical Trials of Antimicrobial Agents for Complicated Urinary Tract Infections, Technical Guidelines for Clinical Trials of Antimicrobial Agents for Simple Urinary Tract Infection (Simple UTIs), Technical Guidelines for Clinical Trials of Antimicrobial Agents for Complicated Abdominal Infections, Technical Guidelines for Clinical Trials of Antimicrobial Agents for Hospital Acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia and solicited public opinions.
4、The NMPA issued Opinions on Further Strengthening the ADRs Monitoring and Evaluation (M&E) System and Capacity Building.
4、The NMPA issued Opinions on Further Strengthening the ADRs Monitoring and Evaluation (M&E) System and Capacity Building.
To conscientiously implement Drug Administration Law, Vaccine Administration Law, Regulations for the Supervision and Administration of Medical Devices, Cosmetic Supervision and Administration Regulation, to effectively strengthen the system and capacity building of ADRs, medical device adverse events, adverse reactions to cosmetics and M&E of drug abuse (hereinafter collectively referred to as ADRs M&E), to constantly improve the M&E capabilities, to comprehensively promote the safety of medical devices and cosmetics used by the public and to protect and promote public health, the NMPA issued Opinions on Further Strengthening the ADRs M&E System and Capacity Building (hereinafter referred to as the Opinions).
The Opinions requires drug regulatory departments at all levels to focus on strengthening the M&E system and capacity construction targets of ADRs, to strengthen the guarantee work from such aspects as organizations and leaderships, guarantee of funds and implementation of responsibility, etc. to accelerate the construction of “one body, two wings” working pattern with ADRs monitoring institutions as professional technical institutions and holders as well as medical institutions fulfilling relevant responsibilities in accordance with the law and emphasize on promoting the following tasks: further strengthening the construction of institutions for ADRs M&E; accelerating the improvement in the institutional system for ADRs M&E; focusing on building a team of monitoring and evaluation personnel; building an efficient national monitoring information system; studying and exploring new methods for M&E of drug safety after marketing; guiding and urging the holders to fulfill the primary responsibility for drug safety; adhering to and consolidating the mechanism for reporting adverse drug reactions in medical institutions; continuing to raise public awareness of adverse reactions; continuing to deepen international exchanges and cooperation.
5、The NHSA issued the Interim Measures for the Administration of Use of Drugs Covered by the Basic Medical Insurance.
5、The NHSA issued the Interim Measures for the Administration of Use of Drugs Covered by the Basic Medical Insurance.
On July 31, the NHSA issued the Interim Measures for the Administration of Use of Drugs Covered by the Basic Medical Insurance. The contents include general provisions, formulation and adjustment of Catalogue of Drugs, use of Catalogue of Drugs, payment of drugs covered by the medical insurance, management and supervision of drugs covered by the medical insurance, supplementary provisions, which is six chapters and 37 articles in total, and come into force on September 1st, 2020.
