Regulatory Environment

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Regulatory Agency for Biological Products

Sources  [ www.mfds.go.kr www.nifds.go.kr www.mfds.go.kr  ]

The Korea Food and Drug Administration (KFDA) became the Ministry of Food and Drug Safety (MFDS) in March 2013. The MFDS is a regulatory agency supervising pharmaceuticals throughout the entire lifecycle from granting a manufacturing license and a product approval, and inspection on GMP compliance to post-marketing surveillance.

MFDS (Biopharmaceuticals and Herbal Medicines Bureau)

The Biopharmaceuticals and Herbal Medicine Bureau has 5 divisions for Biopharmaceutical Policy Division and Biopharmaceutical Quality Management Division.

Biopharmaceutical Policy Division

Establishes & coordinates safety management policies for biopharmaceuticals; creates & revises policies for biopharmaceuticals, transplantation materials and blood plasma
Supports exports and involves in international cooperation

Biopharmaceutical Quality Management Division

Establishes & runs comprehensive domestic/international inspection plans regarding biopharmaceutical manufacturing, quality management criteria and human transplantation materials management
Establishes & coordinates biopharmaceutical supervision/monitoring plans; establishes/runs GMP training/capability building plans

NIFDS (Biopharmaceuticals and Herbal Medicines Evaluation Department)

The affiliated National Institute of Food and Drug Safety Evaluation (NIFDS) aims to improve public health and well-being through scientific safety evaluation of food and drugs. The NIFDS was initially established as a research institute, called the National Institute of Safety Research, under the Ministry of Health and Social Affairs in December 1987. Since then, it was reorganized under the MFDS in 2017. (6 Departments 39 Divisions 6 Department 41 Divisions).

Vaccine Division& Blood Products Division

Responsible for National Lot Release System

Biopharmaceuticals Review Management Division

Operates Pre-review system and deliver applications to each management and review division

Biologics Division

Reviews & evaluates quality, safety and efficacy of biologics & biopharmaceutical diagnostics products
Approves domestic and import related products

Recombinant Protein Products Division

Reviews & evaluates quality, safety and efficacy of recombinants
Approves domestic and import related products

Cell and Gene Therapy Products Division

Reviews & evaluates quality, safety and efficacy of cell therapies, gene therapies, tissue-engineered products
Approves domestic and import related products

A Global Leader in Biopharmaceutical Regulations

Korea leading international regulations on biosimilar technologies

Korea is proactively building advanced approval/review systems for biosimilar products. In July, 2009, Korea became the third country after EU nations and Japan to put in place approval/review and evaluation guidelines for biosimilar products. And in 2011, Korea published guidelines on safety and efficacy evaluation for biosimilar products.

The worlds first stem cell therapy product approved

Stem cell therapies have a potential to treat what used to be untreatable conditions, offering new treatment options for those suffering from incurable diseases. To facilitate the prompt introduction of safe and effective stem cell products into the market, the MFDS has proactively developed and established an optimal review mechanism different from the ones for existing medicinal products.

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