Imported anti-cancer drugs are expected to cut prices by 10% |

Medical Network April 25th The import of pharmaceutical products successively issued two important documents.

On April 24, the State Drug Administration issued the “Announcement on Matters Concerning the Import Clearance of Pharmaceutical Raw Materials” (No. 8 of 2018) to standardize the import clearance of APIs and pharmaceutical excipients.

On April 23, the Customs Tariff Commission of the State Council issued the “Announcement on Reducing Import Tariffs on Drugs.” Starting May 1st, all generic drugs including anticancer drugs will be used at a provisional rate, with biological anticancer activity. The import tariffs for base medicines and imported Chinese medicines have actually dropped to zero, and this adjustment will eliminate 28 import tariffs on Chinese medicines.

It is not difficult to see that China is taking measures such as tariff adjustments and import customs clearance, and actively expands imports to better meet the people. health The need to adopt new initiatives for opening up is conducive to maintaining an open and inclusive multilateral trade system and creating shared development results.

The demand for imported raw materials and accessories continues to increase, and the country naturally introduces import customs regulations that adapt to the new situation. In fact, there are many details in the import declaration process. enterprise For example, if the materials are prepared in advance and the documents are complete, the customs clearance will be smooth.

For imported APIs, the importing entity may go through the "Customs Clearance Form for Imported Drugs" at the port drug regulatory agency with the raw material drug approval certification documents, certificate of origin, packing list, shipping paper, freight invoices, and factory inspection report.

(1) "Imported Drug Registration Certificate" for imported APIs (Announcement No. 146) (Registration of the State Administration of Food and Drug Administration on Adjusting APIs, Pharmaceutical Excipients, and Medicine package The announcement of the review and approval of the matter") The imported raw material medicine approved before the issuance and the "imported drug registration certificate" shall continue to be valid for the validity period. If the validity period expires, the "imported drug registration certificate" shall be provided and may be used in the original medicine. Or for research use.

(2) Obtain the registration number according to the requirements of Announcement No. 146, and have identified as the API approved for use in the listed preparations. The portal of the Drug Review Center of the State Food and Drug Administration shall be provided to the public The results of the 'Raw Drug Registration Data' search results are provided for the use of the pharmaceutical companies using the drug substance, or for research use.

(3) Obtaining the registration number according to the requirements of Circular 146, not identifying the APIs that are approved for use in the marketed pharmaceutical preparations, and providing the results of the 'API registration data' publicized by the website of the website of the PCC for public use only for research purposes.

(IV) "Imported Pharmaceutical Approval Documents" for APIs: If the APIs intended for research use do not have a registration number, an "Imported Drug Approval Document" should be provided for research use only.

(5) Other approval documents permitting the import of APIs.

For the inclusion of the "Regulations on the Adjustment" jointly listed in the former State Food and Drug Administration and the General Administration of Customs <进口药品目录>Announcement on Trade Names and Numbers (No. 104, 2011) Attachments for Pharmaceutical Excipients, Imported Units may be accompanied by Pharmaceutical Excipients, Certificate of Origin, Certificate of Origin, Packing List, Bill of Lading, Freight Invoice, Factory Inspection Report Such as data, to the port drug regulatory authorities for "imports of drug clearances." The port drug regulatory authorities should indicate in the "Imports of Drugs Customs Clearance", "This product is a medicinal auxiliary materials, non-drugs, no port inspection." Not listed The other pharmaceutical excipients listed in the “Catalogue of Imported Drugs” above do not need to go through the “Imported Drugs Customs Clearance Form”. The matters related to import customs clearance shall be implemented in accordance with the relevant provisions of the customs authority.

(1) Pharmaceutical excipients, "Imported Drug Registration Certificates." Pharmaceutical excipients approved before the issuance of the No.46 document, the "Imported Drug Registration Certificate" shall continue to be valid for the validity period. If the validity period expires, the "Imported Drug Registration Certificate" shall be provided. 》, The imported pharmaceutical excipients can be used in the original drug, or for research use.

(II) Obtain the registration number according to the requirements of No. 146 Announcement, and have identified the pharmaceutical excipients that are approved for use in the marketed preparations, and provide the results of the search results of the “Pharmaceutical Excipients Registration Data” publicized by the drug review center portal website. The pharmaceutical excipients are used by the manufacturer or for research use.

(3) To obtain the registration number according to the requirements of Circular 146, which has not yet been identified as pharmaceutical excipients approved for use in the marketed preparations, the search results of the 'Pharmaceutical Excipient Registration Data' publicized by the drug review center portal website for the public should be provided. use.

(iv) Other approval documents permitting the import of pharmaceutical excipients.

Conformance assessment not only screens for preparations but also eliminates excipients

For generic drugs, the technology of certain varieties of preparations, raw materials, etc. still have a relatively high technical threshold. The advantages of high-quality excipients are gradually emerging, and consistency assessment not only filters the preparations, but also eliminates some excipients.

In the consistency assessment, the research of raw materials is an important link. At present, the whole industry of raw materials and accessories in China is still relatively decentralized, and the level of preparations varies from one manufacturer to another. In particular, the situation of raw materials for some varieties has important influence on the efficacy of pharmaceuticals. Analysts Reminder: In the current consistency assessment, a considerable number of companies encountered setbacks in the exploration of raw materials.

President of Ambow Berry Pharmaceuticals, Cao Jiaxiang, deputy director of the original Teva North American agent R&D center, told reporters that if the injection is a solution, it requires the same specifications as the original excipients, the same dosage, and the same process. The requirements for the company's analytical and technical capabilities are more stringent. The excipients for oral agents may be different, and the solution injection excipients must be the same because they are exempt from BE. This means that the analysis of the original research must be more thorough.

The R&D and technical level of pharmaceutical excipients in China is low, especially in the phase of new drug R&D and generic drug conformity assessment. Advantages of imported excipients are gradually emerging. For example, microcrystalline cellulose, imported varieties will have clear functional indicators, but domestically produced varieties often Lack of such indicators, which led to pharmaceutical companies are more inclined to purchase imported materials.

Under the promotion of the conformity assessment of generic drugs, the raw material standards will be more in line with international standards. On the one hand, it will contribute to the overall upgrading of the auxiliary materials industry. On the other hand, there will be a large number of new, high-end imported pharmaceutical excipients entering the Chinese market. The market size of accessories is expected to increase significantly.

28 import tariffs on pharmaceuticals cancelled, imported anticancer drugs are expected to cut prices by 10%

The Customs Department of the Ministry of Finance disclosed that according to the decision of the 4th executive meeting of the State Council, the drug The demand, improve the supply of drugs, improve the level of domestic medical care, this adjustment will cancel 28 import tariffs on drugs.

Anti-cancer drug containing alkaloids and their derivatives (mixed or non-mixed, used for controlled doses or retail packaging), this time the rate has dropped from 5% to zero.

After adjustment, except for a few varieties of specialty drugs such as Angong Niuhuang Pills and some alkaloids, the vast majority of imported drugs, especially those with actual imports, will achieve zero tariffs.

Analysis of the financial sector, with a significant reduction in the production of anti-cancer drugs, the taxation of import value-added tax, the adoption of centralized government procurement, the timely inclusion of imported innovative drugs, especially anti-cancer drugs, in the Medicare reimbursement catalog, accelerating the import of innovative drugs, etc. The introduction of comprehensive measures will further reduce the burden of drugs for domestic patients, especially cancer patients, and allow patients to have more medication choices. The reporter learned that some experts estimate that after the implementation of new measures, the price of imported anticancer drugs in China It is expected that the price will drop by 10%, so that more patients will be able to afford imported anti-cancer drugs.