The Ministry of Internal Affairs and Communications announced the 15th
Seven cases, including the withdrawal of the withdrawal from the obligation to register the medicinal product
In the future, drugs with a temporary increase in use due to unstable suppliers or substitutes will be excluded from the price of the drug. When developing physiological saline, glucose solution, etc. Unregistered raw medicine may be used.
On July 15, the Korean Pharmaceutical Biotechnology Association stated that seven recommendations of the pharmaceutical and biotechnology industry were involved in achieving "regulatory innovations in the new industrial sector" announced by the State Administration Office on 15 January.
The recommendation included the exclusion of certain injectable materials, such as glucose, from the obligation to register the product. In the meantime, it was difficult to develop new injections due to regulations requiring the use of registered raw materials for all injections for new product licenses. In the future, it will be decided to exclude injectables such as physiological saline solution, glucose solution and injection for the dietary supplement into "all injection ingredients" that are the subject of the authorization of the active substance.
In the case of imported generic medicines, exceptions were made only for safety and efficacy tests only if they were received in foreign pharmacies. The change plan will improve the transparent drug approval system by modifying related notifications by appropriately adjusting the scope of the submission of generic drug data.
In addition, pharmaceutical companies that are required to collect the medicinal product shall provide information on the distribution of the medicinal product to be withdrawn. Manufacturers and importers of medicines must withdraw their drugs due to safety and efficacy problems, etc. And the exact position of the distribution and delivery of the drug is unknown. Accordingly, distribution information containing the end position of the medicinal product to be withdrawn (position information from the date of collection instruction) and the like is provided to the registrant.
At the same time, the approved minutes are discussed and discussed at previous audit meetings with the relevant departments of the Food and Drug Administration, the Food and Drug Administration, the Food and Drug Administration and the approval and notification of medicines. In the countries targeted for export, it was not possible to use it as an explanatory material.
In addition, if the use of substitute medicines is increased due to unsold medicines or unstable offer / In addition, the company intends to simplify the approval of gene therapy products approved by the government using the online system.
In addition, companies that have obtained a license for the same generic medicines will be able to conduct a joint investigation. While the original drug companies do not follow a market survey, the first licensed generic pharmaceutical companies are obliged to investigate without exclusive sales benefit
The association said: "This is an example of a good public-private partnership, because the voices of industrial sites are actively reflected and lead to the improvement of the actual system"
Jeon Ye Jin reporter [email protected]
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