Attention to the pharmaceutical industry! The new rules will be implemented from March

[China Pharmaceutical network industry news] in 2019, new policies for the pharmaceutical industry have been continuously issued, including the draft of vaccine management law (Draft), the release of national pilot program for drug centralized collection, etc Since March, another batch of new regulations are about to be implemented The author combed or related to the new provisions of the pharmaceutical industry, for industry reference only Opening of new business license on December 24, 2018, the General Administration of Market Supervision issued a notice on opening of new business license, requiring all kinds of market entities approved by the registration authority to establish, change registration and reissue business license from March 1, 2019 to issue new business license According to the adjustment, the layout of the new business license is uniformly adjusted to horizontal version, with original and copy; the two-dimensional code function of the original business license is uniformly adjusted, and a prompt is added: scan the two-dimensional code and log in the "national enterprise credit information publicity system" to learn more registration, filing, permission and regulatory information In addition, according to the applicant's willingness and the principle of application, we will promote the work of changing licenses in an orderly manner The existing market entities may continue to use the original business license or apply for a new one In other words, the old business license is not useless Pharmaceutical enterprises may continue to use the old business license or apply for a new one On February 22, the State Food and Drug Administration and other four ministries and commissions announced that from March 1, 2019, the general VAT payers who produce, sell, wholesale and retail rare disease drugs can choose to pay the VAT according to the simple method and the 3% collection rate For the imported drugs with rare diseases, the import value-added tax shall be reduced by 3% This means that a large number of pharmaceutical enterprises will benefit from tax reduction WHO defined the incidence rate of 0.65 to 1 per thousand as a rare disease At present, there are more than 20 million patients with rare diseases in China, and 121 kinds of rare diseases are included in the first batch of rare diseases catalogue According to the industry, the R & D cycle of rare disease drugs is long, the investment is relatively large, and the market demand for a single drug is limited, resulting in the mismatch between input and output, and the enthusiasm of many pharmaceutical enterprises is not high With the publication of the catalogue of rare diseases in China, the reduction of taxes and prices of rare disease drugs, the establishment of rare disease alliance, and the preferential policies given by relevant departments to enterprises in terms of taxes, all research institutions and pharmaceutical enterprises will be further promoted to stimulate their innovation vitality, produce more rare disease drugs in China, and greatly reduce drug costs The revised agency Ordinance will come into force on March 1 It is understood that agency service runs through the whole process of intellectual property creation, application and protection, and is a professional service combining law and technology According to the actual situation of the agency industry, the new "agency regulation" has improved the access system of agency agencies and agents, the norms of agency practice, the inspection and supervision system and legal responsibility, which will provide institutional support for the healthy development of the agency industry In the pharmaceutical industry, protection is the main channel for new drugs to monopolize the market With the improvement of agency industry, it will provide more powerful support for new drug protection Tax invoicing is more convenient In order to optimize the business environment, from March 1, the tax bureau will further expand the pilot scope of VAT special invoice issued by taxpayers of large and small scale, and expand the scope of taxpayers who cancel VAT invoice certification to all general taxpayers The industry pointed out that in the pharmaceutical industry, such as the compliance path of value-added tax, the penalty of buying and selling invoices, the consequences of off balance sheet operations, the risk of commercial bribery, tax evasion and tax evasion, etc., are all the time bombs of entrepreneurs With the introduction of new policies related to VAT invoices, under the double sword of administrative regulations and tax big data, there will be no place for drug companies to hide illegal behaviors and operations such as false invoices.