echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical World News > The characteristics and highlights of the revision of the Drug Administration Law are analyzed

    The characteristics and highlights of the revision of the Drug Administration Law are analyzed

    • Last Update: 2021-02-03
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    1. Delete the words "to the administrative department for industry and commerce for registration on the basis of the Drug Production License" in the first paragraph of Article 7.
    , delete the words "to the administrative department for industry and commerce for registration on the basis of the Drug Business License" in the first paragraph of Article 14.
    , delete Article 55.
    , replace Article 89 with Article 88 and delete the "Article 57" from it.
    , delete Article 100.
    shall come into effect as of the date of publication.
    The Drug Administration Law of the People's Republic of China has been amended accordingly and re-published in accordance with this Decision.
    , what are the features and highlights of the revision of the Drug Administration Act? The author gives you one by one analysis.
    1, delete the words "to the administrative department for industry and commerce for registration on the basis of the Drug Production License" in the first paragraph of Article 7.
    : The establishment of a pharmaceutical production enterprise shall be approved by the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government of the enterprise and issued with the Drug Production License, and shall be registered with the administrative department for industry and commerce in accordance with the Drug Production License. Drug production shall not be allowed without a "drug production license".
    A brief analysis: do not need to take the "drug production license" to the industrial and commercial administrative departments for registration, said that after the new application drug enterprises in the industrial and commercial administrative departments for registration, only according to the regular enterprises to register, not in accordance with the "business scope of business scope registration regulations" in the scope of business of the company application for registration has laws, administrative regulations and the State Council decision required to report before registration approved items, submit the relevant approval documents or license copies or licenses. "What is it to register?" It is to handle the business license of the enterprise legal person, the tax registration certificate, etc.
    2, delete the words "to the administrative department for industry and commerce for registration on the basis of the Drug Business License" in the first paragraph of Article 14.
    The establishment of a wholesale pharmaceutical enterprise shall be approved and issued by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government of the enterprise, and the establishment of a drug retail enterprise shall be approved by the local drug supervision and administration department at or above the county level where the enterprise is located and issued a drug business license, and shall be registered with the administrative department for industry and commerce in accordance with the Drug Business License. Companies may not operate drugs without a Drug Business License.
    analysis: As in the analysis of the last Drug Production License, when the administrative department for industry and commerce registers, it is only required to register according to the regular enterprise.
    drug wholesale enterprises and drug retail enterprises to handle the "drug business license" process and the "drug production license" process is about the same, but part of the submission of information and audit cycle is different.
    3, delete Article 55.
    West: "In the case of medicines priced by the government and guided by the government in accordance with the law, the competent government price department shall, in accordance with the pricing principles stipulated in the Price Law of the People's Republic of China, reasonably formulate and adjust prices in accordance with the average cost of society, the market supply and demand situation and social affordability, so as to achieve a consistent quality price, eliminate inflated prices and protect the legitimate interests of drug consumers." Pharmaceutical production enterprises, operating enterprises and medical institutions must implement government pricing, government-directed prices, and may not raise prices in any form without authorization. Pharmaceutical production enterprises shall, in accordance with law, truthfully provide the government price authorities with the cost of production and operation of drugs, and shall not refuse to report, falsely report or conceal them. The
    : There are three kinds of pricing behavior of drugs in our country: government pricing, government-directed pricing, and independent pricing. The deletion of this article paves the way for the new drug price negotiation mechanism, so that medical institutions can independently negotiate the purchase of drugs that belong to the government pricing, government-directed prices when removing regulatory restrictions, so that hospitals can obtain the proceeds of reducing the purchase price of this part of the drug, hospitals have the incentive to implement drug procurement price reduction behavior. But from the current bidding policy, in the short term, hospital sales of drugs will not rise. After that, it is the standard of payment for health insurance that will have a greater impact on drug prices.
    4, replace Article 89 with Article 88 and delete the "Article 57" from it.
    Article 89 Of the Original Text: Any violation of the provisions of Articles 55, 56 and 57 of this Law on drug price management shall be punished in accordance with the provisions of the Price Law of the People's Republic of China.
    Article 56 The production enterprises, operating enterprises and medical institutions of medicines shall, in accordance with the principles of fairness, reasonableness, good faith and conformity in quality, set prices and provide reasonably priced medicines to drug consumers.
    enterprises, operating enterprises and medical institutions of pharmaceutical products shall abide by the provisions of the price department under the State Council on the management of drug prices, formulate and mark the retail prices of drugs, and prohibit price fraud that is profiteering and harming the interests of drug consumers.
    Article 57 of the article: "Pharmaceutical production enterprises, operating enterprises and medical institutions shall, in accordance with law, provide the competent government price authorities with information on the actual purchase and sale price of their drugs and the quantity purchased and sold." "
    : Article 55 of which has been deleted above, this change has not had much impact on the current market, but only for the penalty according to the provisions of the change.
    5, delete Article 100.
    : If a drug production license or a drug business license are revoked in accordance with this Law, the drug regulatory department shall notify the administrative department for industry and commerce to handle the change or cancellation of registration.
    : Because the provisions of holding the Drug Production License and the Drug Business License to register with the administrative department for industry and commerce have been deleted, according to the logical relationship, the drug supervision and administration department does not need to notify the administrative department for industry and commerce.
    Overall, the revision of the Drug Administration Law, in addition to rationally simplifying the workflow of the executive branch, focuses on echoing the previous draft of the National Development and Reform Commission's "Proposal for the Promotion of Drug Price Reform" and the "Public Hospital Procurement Implementation Opinion" led by the Health and Planning Commission.
    to bring drug prices closer to the market's real prices by further removing the restrictions above the regulations, allowing hospitals to dominate price pressures, tender price limits and health-care adjustments.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.