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Time of issue:2019-12-05 00:00:00
Industry News
Notice on the implementation of doping ingredients contained in medical devices in accordance with the relevant provisions of the Anti-Doping Regulations
The Food and Drug Administration of the province, autonomous region and municipality directly under the Central Government (Drug Supervision Administration):
Recently, our bureau received a letter from the local food and drug supervision and administration department, reflecting that some medical devices incorporating medical equipment contain stimulant ingredients. After research, if the medical device combined with medical equipment contains stimulant components, the contained stimulant components shall be implemented in accordance with the relevant provisions of the Anti-Doping Regulations.
State Food and Drug Administration
May 16, 2008
EU RoHS Directive revised further affects the export of Chinese medical products
EU member states continue to strengthen law enforcement, the impact will inevitably directly affect China. Recently, the European Union's green directive RoHS ("Restriction on the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive") has been revised to extend the scope of application to medical and monitoring equipment. In addition, 4 types of hazardous substances have been added as priority evaluation substances, which will It has a major impact on the export of China's home appliance companies.
The European Commission issued the "Recommendation on the Rewriting of the European Parliament and Council Directive on the Restriction of the Use of Certain Hazardous Substances (RoHS) in Electrical and Electronic Equipment (COM (2008) 809 Final Edition)", which proposed to rewrite the current Directive 2002 /95/EC (RoHS Directive). The committee’s proposal maintains key elements of the current directive, such as the list of prohibited substances (no addition or removal of substances) and the possibility of granting exemptions for these substances in certain application areas.
The proposal includes the following major changes:
1. Clarified the scope and definition, especially by establishing a binding list of products to define the scope of the RoHS directive.
2. The use of EU product sales, especially the relevant provisions already used in the package of regulations on national sales supervision activities and mechanisms for product conformity assessment.
3. Adapted the exemption procedure, such as granting an exemption by adopting additional socioeconomic standards, and requiring applicants to analyze alternatives before submitting the request, and the maximum validity period is 4 years.
4. A stepwise approach is included in the RoHS scope of medical devices and control and monitoring instruments.
5. Established a clear identification mechanism.
Shanghai Medical Device Industry Association
Basic medical devices and generic drugs will be the biggest beneficiaries in the future
Within three years, governments at all levels are expected to invest 850 billion yuan for medical and health system reform. These 850 billion yuan are incremental, and split into 300 billion yuan, 300 billion yuan and 250 billion yuan.
Government investment is mainly in three categories: medical insurance subsidies, that is, subsidies for urban residents and new rural cooperative medical insurance, about 390 billion yuan; public health about 60 billion yuan; and various medical institutions will usher in 400 billion yuan.
General medicine and basic medical equipment will be the biggest beneficiaries of medical reform in the next three years.
After more than five months of public consultation and revision, the State Council officially announced the "Opinions of the Central Committee of the Communist Party of China on Deepening the Reform of the Medical and Health System" (the final draft of the new medical reform plan). According to the new medical reform plan, the next three years will support medical reform For five key reforms, governments at all levels need to invest 850 billion yuan. This is a huge new investment.
The 850 billion yuan investment is undoubtedly the most eye-catching part of the medical reform plan. This investment will be mainly reflected in three aspects: for medical insurance subsidies, that is, to subsidize urban residents and the new rural cooperative medical insurance, etc., about 390 billion yuan; public health About 60 billion yuan; about 400 billion yuan for various medical institutions. Some analysts believe that the three-year investment of 850 billion yuan should be a base, the actual number may exceed expectations.
In addition to financial investment, the medical reform plan shows the government's attitude towards steadily increasing investment in medical and health undertakings. For medical manufacturing, retail and medical services, the opportunities and impacts brought by medical reform are different.
Pharmaceutical manufacturing: hidden opportunities
Medical reform plan mentioned that it is necessary to "preliminarily establish a national essential medicine system; establish a scientific and rational selection and adjustment mechanism for essential medicines and a supply guarantee system."
In this regard, Wang Shaohua, general manager of Hangzhou Zhencheng Pharmaceutical Co., Ltd., the first B2B company with Internet drug trading qualification in the country, believes: "Community medical care vigorously implemented by the new medical reform must use 100% of the drugs in the essential drug list. Therefore, the first beneficiary medicine The manufacturing enterprises will be those with the approval for the production of essential medicines. Not only that, the plan also mentions that the state will implement bidding for fixed-point production of essential medicines, which means that even if there is an approval, they must obtain the qualification for fixed-point production."
He believes that, based on the above factors, large state-owned pharmaceutical companies will usher in the best historical development opportunities in this round of medical reform. At the same time, those manufacturing companies that have entered the list of essential medicines and have exclusive approvals are even bigger winners. "And due to the volume of essential medicines, objectively it will also have a certain impact on medicines that are not listed in the essential medicines list. Therefore, in the future, there may be a large number of orders from designated manufacturers, and their own production capacity cannot keep up, so through mergers , Acquisitions and other ways to expand production capacity, and eventually there will be an increase in industry concentration." Wang Shaohua told reporters.
Many powerful pharmaceutical companies also believe that for them, the new medical reform undoubtedly hides opportunities.
"This means that the state has strengthened the management of medicines. In this case, homogenized products will lack a competitive advantage, and the competitiveness of branded products will be highlighted." Zhao Jianghua, vice president in charge of medicine of Huali Group In an interview with a reporter, I analyzed and said.
Huali Group owns 3 pharmaceutical listed companies, Huali Pharmaceutical (000607SZ), Kunming Pharmaceutical (600422SH), and Wuhan Jianmin (600976SH), and has maintained a world leading level in the production and research and development of artemisinin and its derivatives. At the same time, it also owns famous brand medicines including "Longmu Zhuanggu Granules" and "Jianmin Throat Tablets".
Because of its advantages in technology and brand, Zhao Jianghua believes that this medical reform is "a good thing for Huali". "At present, we have already applied for four or five products in the national essential medicine catalogue. After approval in the future, the sales of these medicines will have a greater increase." Zhao Jianghua
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