2020 major policies affecting the entire pharmaceutical industry

Quietly over half of 2020, recently, the pharmaceutical industry policies are released intensively, overwhelming, children's medicines are welcome, base drugs are strained, antibacterial drugs form a "1+X" medication mode, and the third batch of volume purchases gathers arrows...
 
2020 is destined to be an extraordinary year. The pharmaceutical industry is changing rapidly, taking stock of the heavy policy of the pharmaceutical industry in the first half of 2020, spying on the industry trend and exploring new opportunities.
 
The policy of children's medicine continues, and the development of children's medicine is good
 
On June 12, CDE released the "Guidelines for the Development of Pharmaceuticals for Children (Chemical Drugs) (Draft for Comment)", which aims to fill the gaps in the guidelines for the development of pharmaceuticals for children in China, and provide research and development ideas and technologies for the pharmaceutical development of childrens medicine Guidance to promote the research and development of children's medicines to meet children's medicine needs.
 
On May 18, CDE issued a notice on publicly soliciting opinions on the "Technical Guiding Principles for Real-World Evidence to Support Children's Drug Development and Review (Exposure Draft)". This is the first technical guideline on real-world applications since the State Food and Drug Administration's guidelines on the release of real-world evidence to support drug development and review in 2020. The industry believes that real-world research on children's medicines will drive more children's medicines to market faster.
 
As the market's demand for children's medicines grows, the successive release of children's medicines policies will encourage the research and development of pediatric medicines and promote the further expansion of the pediatric medicines market.
 
The base medicine is changing: the anti-bacterial medicine "1+X" medication mode, the base medicine becomes an important hospital evaluation index
 
On June 9, the National Health and Health Commission issued two heavy documents one after another. The first one was the draft for the consultation on "Administering the Clinical Application of Antibacterial Drugs in the New Situation." Medical institutions are required to optimize the supply list of antimicrobial drugs by combining the "1+X" medication mode dominated by essential drugs ("1" is the national essential medicine list and "X" is a non-essential medicine).
 
On the same day, the National Health and Health Commission issued a notice on the work related to the collection of performance evaluation data for public hospitals of the second and third grades in 2019. The notification requires that the use of essential medicines becomes an important assessment indicator. Among them, the evaluation indexes of essential medicines in the tertiary hospitals include: the proportion of outpatient prescriptions of essential medicines, the utilization rate of essential medicines in inpatients, and the proportion of the number of essential medicine purchases, and the evaluation index of essential medicines in second-level hospitals is the amount of essential medicine purchases Proportion.
 
At the beginning of June, the National Health and Drug Administration’s Department of Pharmacy’s 9 work points for 2020, including 7 related to medicines, 3 related to basic medicines, and the content of essential medicines bear the brunt, is the first key task of the Department of Pharmacy in 2020, and Indicate that the catalog selection and adjustment procedures should be optimized and catalog adjustment work should be started in due course.
 
In addition, as early as February 26, the National Health Commission, the Ministry of Education, the Ministry of Finance, the Ministry of Human Resources and Social Security, the State Medical Insurance Bureau, and the State Food and Drug Administration and other six departments jointly issued "On Strengthening the Medical Administration of Medical Institutions to Promote Rational Use of Drugs" Views". The "Opinions" suggest that medical institutions at all levels should form a "1+X" medication model dominated by essential drugs ("1" is the national essential medicine list; "X" is a non-essential medicine).
 
It can be seen that 2020 is a year of major changes in basic drugs, and changes in basic drugs will be made in terms of medical insurance payment and adjustment of the list of basic drugs.
 
Strictly crack down on CSO violations and correct unhealthy practices in the field of pharmaceutical purchases and sales and medical services
 
On June 5, nine ministries and commissions including the State Health and Health Commission, the Ministry of Industry and Information Technology, the Ministry of Public Security, the Ministry of Finance, the Ministry of Commerce, the State Administration of Taxation, the State Administration of Market Supervision and Administration, the State Medical Insurance Bureau, and the State Administration of Traditional Chinese Medicine jointly issued the "Notice of the Main Points of Unhealthy Practices in the Field of Pharmaceutical Purchase and Sale and Medical Services", continue to strengthen anti-corruption in medicine
 
The notice lists that the collection of medical insurance costs has become the focus of the crackdown. In addition to the traditional medical marketing bribery-carrying out special rebate management activities, the CSO is specifically listed as the focus of crackdown.
 
The pharmacy filing system will start again
 
On June 5, the State Food and Drug Administration issued the "Administrative Measures for the Filing of Medical Representatives (Trial) (Draft for Comment)". This is the second time the draft opinion for the filing of pharmaceutical representatives has been released after two years. (The last time the FDA asked for opinions on the medical representative filing system was at the end of 2017. Measures (Trial Implementation) (Draft for Comment)".
 
The core requirement is still that first, medical representatives shall not undertake the task of drug sales, and second, that medical representatives shall not carry out academic promotion and other related activities within medical institutions without filing. Representatives will return to academic standards.
 
Injectable consistency evaluation officially started
 
On May 14, the State Administration of Drug Administration issued an announcement to carry out the evaluation of the consistency and quality of generic drugs for chemical injections. On the same day, CDE released the "Technical Requirements for the Consistency Evaluation of the Quality and Efficacy of Generic Drugs in Chemical Injections", "Technical Requirements for the Consistency Evaluation of the Quality and Efficacy of Generic Drugs in Chemical Injections (Special Injections)", and "The Quality and Efficacy of Generic Drugs in Chemical Injections" "Conformance Evaluation Declaration Document Requirements", which marks the official start of the consistency evaluation of injections.
 
Industry insiders said that the consistency evaluation will reconstruct the competitive landscape of generic drugs, forcing more domestic generic drug companies to transform from low-end to high-end generic.
 
The third batch of state procurements is on the line
 
From May 14th to 15th, the national joint procurement will hold a national volume procurement meeting at the Shanghai Pharmaceutical Office. The third round of volume procurement is expected to be in July.
 
At the same time, according to industry estimates, in addition to the 25 varieties purchased by 4+7, 33 varieties from the second round of centralized procurement, and more than 200 varieties from the third round of purchases are available for selection. At the same time, based on the experience of the previous two rounds, the new round of procurement with volume will surely fall into price fighting again. With little time left in July, I wonder if companies are ready to fight again.
 
Drug registration, production supervision and management measures announced; supporting documents issued in batches
 
April 31, Chemical Drug Registration Classification and Declaration Information Requirements (Consultation Draft), Biological Product Registration Classification and Declaration Information Requirements (Consultation Draft), "Special Provisions on Chinese Medicine Registration Management (Consultation Draft)", "Vaccine Production Circulation" Dozens of documents including the Administrative Regulations (Draft for Comment) were issued by the State Food and Drug Administration. Chinese medicine, chemical drugs, biological products, as well as drug registration classification, application requirements, technical guidance for change, and acceptance guidelines are all included.
 
In addition, the measures for drug registration and production supervision and management will be announced on March 30 and implemented on July 1. Strengthen drug quality and safety risk control, standardize and strengthen drug supervision, ensure drug safety, effectiveness and quality control to lay the foundation for the rule of law.
 
Opening of the New Year's Drama, the second batch of national mining selection in the national collection; full implementation
 
On January 17th, the second batch of state-organized centralized drug procurement work was carried out in Shanghai, and the results of the proposed selection were announced late at night on the 17th. Among the 33 varieties collected this time, 32 were successfully purchased, and a total of 100 products were selected. 122 companies participated, resulting in 77 companies to be selected. Compared with the lowest purchase price in 2018 in the Union region, the proposed price selection has dropped by an average of 53%, and the highest drop has reached 93%. In particular, the major price reduction of drugs commonly used in chronic diseases such as acarbose and glimepiride will significantly reduce the price. Patient burden.
 
On March 18th, the document "Letter on Actively and Steady Promoting the Implementation of the Second Batch of National Organizations for Centralized Purchase of Drugs" document issued by the National Medical Insurance was circulating in the industry. The document requires that the second batch of collective mining and landing work be fully launched in April. For individual enterprises that cannot be supplied normally due to the impact of the epidemic situation, a delay in supply can be negotiated to determine the start of the operation no later than June.
 
In addition, the document requires actively promoting the concentration of provincial and high-value consumables. Before the end of September, pilot provinces of comprehensive medical reform should take the lead in carrying out volume procurement of medicines and high-value consumables that are not included in the centralized procurement of national organizations. At this point, the second batch of national centralized procurement has landed.
 
In the first half of 2020, industry policies will be intensified in the first half of the year. In July, the third batch of national gatherings will soon be lifted. The drugmakers will have no time to pant, and the cerebral nerve strings will be tight again. In addition, the annual medical insurance dynamic adjustment will start in the second half of the year. , Drug prices may become the focus of attention again. So, in the second half of 2020, what other heavy policies will be released and how will the policy-oriented weather vane change?