and the import of generic drugs should be the patent expired original research drugs at present there is no imitation of the product, or the original research has not been listed in the domestic clini

Medical Network November 5 News Next batch of a large number of approved imported new drugs, will continue to be clinically in urgent need of foreign new drugs. November 1, "on the release of the first batch of clinical urgent need for foreign new drug list Notice" released, published 40 products.

The 40 imported new drugs will be quickly approved for listing. So, what are the characteristics of the wave of imported drugs launched in 2017? What kind of tide will the future evolve?

What products will be available for imported generic drugs that are closely watched?

The imported new drugs approved in 2018 were mainly anti-tumor drugs and respiratory drugs, of which anti-tumor drugs were mainly single-drug drugs, respiratory drugs to the main inhalation agent.

May 23, 2018 State Drug Administration, National health Health "On optimization" issued by the Commission Drug registration The notice on the review and approval of matters (23rd of 2018) and the circular of the state Drug Administration of July 10 on the technical guidelines for the acceptance of data on overseas clinical trials of medicines (No. 52nd of 2018) are regarded by the industry as the main policies of good imported medicines. Priority review is also a major policy for the import of new drugs, 2018 years ago in the three quarter approved 6 imported tumor new drugs pethidine Bercilli capsule, citrate Kafizomi capsule, orapalib tablets, Serry. Capsule, Paboli monoclonal injection and Navuliu monoclonal injection, are ' compared with the existing treatment methods have obvious therapeutic advantages '

To expedite the approval of approved products on the basis of the inclusion of priority review lists. Since 2017, a total of 54 batches have been approved under the new registration classification of chemical drugs, 5.1 categories and 5.2 categories, corresponding to 31 products. Of these, 5.1 categories of products 30, 5.2 Category 1.

Thus, the influx of imported drugs more refers to the clinical need for foreign listings have not yet been listed in the domestic import of new drugs.

GlaxoSmithKline takes the Abarami tablets, the Casonvillantro powder Inhaler (Ⅱ), the fluoride Casonvillantro powder Inhaler (Ⅲ) and the Udon bromide Villantro Powder Inhaler 4 products, becoming the most imported pharmaceutical companies with the largest number of products registered for the new registration and classification of chemical drugs. Most of the indications for inhalants were chronic obstructive pulmonary (COPD) and asthma. The new drug for slow obstructive pulmonary imports was approved in 2018 with GlaxoSmithKline's Villantro bromine ammonium powder inhaler, Boehringer Ingelheim's thiophene bromide Odatro inhalation spray and Novartis's Geelong ammonium bromide inhalation powder spray capsules.

GlaxoSmithKline's furfural Casonvillantro inhalation Powder Mist (Ⅱ) and fluoride Casonvillantro inhalation powder Aerosol (Ⅲ) corresponding indications for asthma is the response. Inhalation agent is also the direction of domestic imitation pharmaceutical enterprises looking for differentiated dosage forms. For example, Hengrui recently declared inhaled ammonium bromide powder and other inhalants;

Haizheng's Sun company Hui is with Novartis signed a Malay acid indinavir inhalation powder, indinavir Datroglon bromide Powder Inhaler Capsules, Geelong bromide inhalation powder with capsules combined with 3 of the exclusive promotion agreement for slow-resistant lung products.

It is expected that the next batch of imported drugs has been approved in large quantities Drug For the clinical urgent need for foreign new drugs. August 8, 2018 the National Drug Review Center on the official website issued the "on the request for overseas listed clinically urgent new drug list opinion notice", published 48 products into the draft for comments. 40 products were published in the notice of November 1, 2018 on the release of the first list of urgently needed foreign medicines. The 8 products deleted, such as Table 2, are currently listed products in China.

These 40 products are expected to be rapidly approved products for imported new drugs.

In addition to the 5.2 declarations in the table, Novartis also declared the consistency of amlodipine benzene sulfonic acid tablets, rishuvastatin tablets, and the consistent evaluation of the Alpha tablets and the threonine peso, which is a transnational drug company that actively layouts the generic drug market. In the Asian region, India and Taiwan, China, are the most active in the layout of Chinese generic drugs. The API filing system has been delayed, with Indian drug companies declaring individual API products in 5.2 categories, but India has a higher number of declared formulations than Japan and South Korea.

Indian companies declare that imported products are less likely to be tumor drugs.

Domestic companies are also actively introducing imported products, such as Sha Mei-Carlo Pine powder inhaler, billion teng Medicine (Suzhou) intends to introduce, Jiangsu Pioneer and Celon Pharma S.A also intend to introduce. India Enterprise Cipla and Runyang Medicine also jointly declared the sand Merlot Air Mist agent. In addition, Shandong Green leaf production industry to introduce Luye Pharma's Leith transdermal patch; The introduction of amlodipine benzene sulfonic acid tablets and the Forpke tablets of hydrogen bromide were introduced.

The rapid approval of imported new drugs shows that China will gradually synchronize with the international, and introduce international standardized treatment to meet the clinical needs of domestic patients to review the direction. Before the import of generic drugs were approved less, it is expected that and declared products belong to the domestic enterprise capacity can be basically satisfied with a certain degree of relevance.

and the import of generic drugs should be the patent expired original research drugs at present there is no imitation of the product, or the original research has not been listed in the domestic clinical needs of drugs. Imported drugs approved by the tide GSK most eye-catching! Novartis, Pfizer actively layouts imported generic drugs