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KOREA DRUG APPROVAL PROCESS

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The Ministry of Food and Drug Safety (MFDSKorean: 대한민국 식품의약품안전처; Hanja: 食品醫藥品安全處; RR: Daehanminguk Sikpumuiyakpumanjeoncheo), formerly known as the Korea Food & Drug Administration (KFDAKorean: 식품의약품안전청), is a South Korea government agency responsible for promoting the public health by ensuring the safety and …

Approval Process

Overview

Overview of Pharmaceutical Approval Process
  • Approve pharmaceuticals whose safety, efficacy, and quality are identified (including pharmaceutical ingredients) through technological review and inspection for their manufacturing and distribution.(「Pharmaceutical Affairs Act」Article 31)
    • Classification of pharmaceuticals : Drug products, pharmaceutical ingredients
    • Classification of drug products : New Drug, Pharmaceutical required for data submission and Generic Drug
      • New Drug refers to a new material pharmaceutical whose chemical structure or original composition is totally different from a pharmaceutical previously approved in Korea or a multiple preparation containing a new material as an active drug substance, which is designated by Minister of Food and Drug Safety. (「Pharmaceutical Affairs Act」Article 2 Subparagraph 8)
      • Pharmaceutical required for data submission refers to not a new drug but a pharmaceutical required for the safety and efficacy evaluation. (Regulation on Pharmaceuticals Approval, Notification and Review (MFDS Notification) Article 2 Subparagraph 8) e.g.) pharmaceuticals with new effectiveness, new composition or increase/decrease of strength of active drug substance, and pharmaceuticals with new route of administration etc.
      • Generic Drug refers to a pharmaceutical which is equivalent to a new drug (reference drug) in terms of active ingredient, dosage form and strength
Data Requirements for Approval
  • New Drug (「Regulation on Safety of Pharmaceuticals」(Ordinance of the Prime Ministerial) Article 9)
    • (Review by Drug Evaluation Department) Safety & efficacy data, specifications & test methods, Drug Master Files (DMF), certificate of manufacturing and marketing(Imported Pharmaceutical) Data such as name and address of manufacturers of active pharmaceutical ingredients
    • (Review by Other Departments) Evaluation data of conducting of Good Manufacturing Practice (GMP)
Figure 1. Dossier for Safety & Efficacy Evaluation
Figure 1. Dossier for Safety & Efficacy Evaluation
Data on Drug Substance
  1. Data on structure identification
  2. Data on physical & chemical properties
  3. Data on manufacturing methods
  4. Data on specifications & test methods are stated
  5. Supportive data on specifications & test methods
  6. Data on test results
  7. Data on reference standards, reagents, and test solutions
  8. Data on containers & packaging materials
Data on drug product
  1. Data on drug product
  2. Data on composition
  3. Data on manufacturing methods
  4. Data on specifications & test methods are stated
  5. Supportive data on specifications & test methods
  6. Data on test results
  7. Data on reference standards, reagents, and test solutions
  8. Data on containers & packaging materials
  • Pharmaceutical required for data submission : Selectively submit data required for safety and efficacy evaluation among submission data for new drug.
  • Generic Drug : Submit bioequivalence test data and quality data instead of safety and efficacy data such as toxicity, pharmacology, clinical trials. 「Regulation on Safety of Pharmaceuticals」(Ordinance of the Prime Ministerial) Article 4 (1) 3
    • Generic drugs are reviewed by Drug Evaluation Department and approved by regional FDAs.
Work Flow for Approval of Pharmaceuticals
  • New drug, Pharmaceutical required for data submission
Work Flow for Approval of Pharmaceuticals
  • In the whole process of drug review and approval, consult with Central Pharmaceutical Affairs Advisory Committee (CPAC), if necessary
  • Product Manager (PM) a general manager from submission, pre-review, supplementation, approval and revision for each product
  • Pre-review system : PM examines submission data and the adequacy of data requirements
  • Product Briefing
    • (Priority) new drug, IMD and when requested by civil petitioner
    • (Participants) civil petitioner, Review Division, Pharmaceutical Policy Division
      Improve efficiency and predictability of review and approval process by enhancing mutual understanding between reviewer and petitioner of a product required for approval process
    • Drug Approval Update
      Weekly withdrawals, monthly approvals, approval report (NDA), evaluation results of safety and efficacy (pharmaceuticals required for data submission)
  • Generic Drug
    • Required Application Documents : Bioequivalence study, GMP documents and CMC(Chemistry, Manufacturing, Controls) data
Figure 1. the Process of Generic Drugs Approval
Figure 1. the Process of Generic Drugs Approval
  • RFDA approve generic drugs via drug approval evaluation
  • In the whole process of drug review and approval, consult with Central Pharmaceutical Affairs Advisory Committee (CPAC), if necessary.

https://www.mfds.go.kr/eng/wpge/m_17/de011008l001.do

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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