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Covid19 Vaccine Authorization Review Period Shortened From 180 Days to 40 Days

The Ministry of Food and Drug Safety (MFDS) of South Korea explained on the 27th the licensing process for new coronavirus infections (Covide 19) vaccines and treatments that are currently being developed domestically and internationally.

A preliminary review of vaccines by foreign pharmaceutical companies is currently underway by the Ministry of Food and Drug Safety. Celltrion, a South Korean antibody drug developer, said it will apply for approval this month.

The drug licensing process begins when manufacturers and importers apply for item permits. When applying for permission, the company shall submit data on non-clinical, clinical and quality necessary for permission prescribed in Articles 31 and 42 of the Pharmaceutical Act to the MFDS. The Ministry aims to shorten the 180-day existing processing period and process it within 40 days through a emergency quick review by the licensing review team.

Vial on a desk 스톡 콘텐츠 - 119153985
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Vaccines, a biological formulation, can be distributed and sold only after the government approves after the additional quality inspection. In the case of the Covid 19 vaccine, the government plans to shorten the processing period of existing national shipment approval, which is usually more than two to three months, and process it within 20 days. Under Korean law, drugs may be manufactured or imported only after obtaining prior approval. Article 85-2 of the Pharmaceutical Affairs Act stipulates procedures for special approval. The head of related ministries, such as the Korea Centers for Disease Control and Prevention, may request the head of the Ministry of Food and Drug Safety to make or import special products to cope with infectious diseases, etc. If approved, they can manufacture or import medicines that are not licensed in Korea.

Vaccines are being tested on phase 3 clinical trials in many companies around the world. As of the 25th of this month, the Pfizer vaccine was approved for emergency use in eight countries, including the United States and the United Kingdom, and was granted conditional permission in the European Union and Switzerland. The Moderna vaccine has been approved for emergency use in the United States. Five products are currently undergoing clinical trials in Korea, and most of them are in the initial stage of phase 1 or 1/2 of phase.

In the case of the treatment, the third phase of the antibody treatment clinical trial is underway at multinational pharmaceutical companies Lilly and Regeneron, and has been approved for emergency use in the United States. Clinical trials are also being carried out to add the effectiveness of Covid19 treatment for existing drugs such as “baritynip,” a drug for arthritis.

In Korea, a total of 15 products (13 ingredients), including antibody treatments, which are being developed as a new Cobid 19 treatment, are undergoing clinical trials.

Source: The Ministry of Food and Drug Safety. (n.d.). Press Release. Retrieved December 28, 2020, from https://www.mfds.go.kr/brd/m_99/view.do?seq=44899&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

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