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发表于 2019-8-18 22:08:07
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从2016 Ministry of Food and Drug Safety White Paper了解到韩国GMP大致等同于PIC/S的GMP(≈EU GMP)。
1. Introduction and Stabilization of GMP that is in Harmony with International Standards
A. Background
1) Introduction and Improvement of the Internationally Harmonized Pharmaceutical Good Manufacturing Practice Regulations
In 1969, at the 22nd World Health Assembly, WHO released requirements for Good Practices in the Manufacture and Quality Control of Drugs (Good Manufacturing Practices, GMP) and recommended that member states adopt the regulation and, on June 28, 1977, Korea started implementing the GMP. After the enactment of Article 22〔Appendix 4〕「GMP」of 「Enforcement Rule of the Pharmaceutical Affairs Act」 in July 1994, MFDS has continuously improved the system in order to strengthen its competitiveness among leading pharmaceutical companies in the global market by securing overall quality of APIs and finished products, introducing a system for inspecting manufacture and quality control of medicinal products by dosage form, requiring GMPs for APIs and finished products, transitioning from evaluation by dosage form to evaluation by item and introducing the ‘validation’system.
2) Joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Harmonization of GMPs
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was formed to improve pharmaceutical quality control system and to internationally standardize GMPs by minimizing confusions and conflicts that may arise during exports and imports due to differences in GMP regulations between nations. The Pharmaceutical Inspection Convention (PIC) which was founded in October 1970 by the 18 nations of the European Free Trade Association (EFTA) later in 1995 expanded to the Pharmaceutical Inspection Co-operation Scheme.
After the 2007 Presidential Advisory Medical Industry Advancement Committee decided on joining PIC/S and signing Mutual Recognition Agreement with advanced countries, MFDS prepared to apply for PIC/S by creating a consultative body consisting of experts from home and abroad in 2011 and submitted the application in April, 2012. worked continuously on internationally standardizing Korean GMPs.
B. Achievements
1) Joining and Acting as a Member of the PIC/S
The application process for joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) takes generally about 4 - 5 years. After an on-site audit conducted by the audit team of PIC/S experts, in Jan. 2014, Korea’s Ministry of Food and Drug Safety (MFDS) was finally approved (effective on July 1) at the PIC/S committee meeting held at Rome, Italy. It only took 2 years, the shortest period in the history, for Korea to join the PIC/S and it was a meaningful result that is comparable to Korea’s joining of OECD since it significantly improved the global trust in Korea as well as in Korea pharmaceutical industry. It was more meaningful since it was the first experience for Korea to join an international pharmaceutical instrument through strict evaluation processes. In addition, MFDS joined PIC/S with its entire regulation as it is, without having to change the system by adopting the PIC/S GMP. This is another great achievement in that Korean GMP regulation has been internationally recognized.
As a member state of the PIC/S, Korea’s MFDS is currently implementing various policies to support Korean pharmaceutical industry in entering into overseas markets. In January 2015, MFDS held a PIC/S-organized, API workshop in Korea and around 140 people including policy authorities and industry representatives around the world participated in the workshop. In April 2015, MFDS invited policy authorities from ASEAN nations, held the KOREA-ASEAN Pharmaceutical GMP Cooperation Conference and promoted Korea’s joining of the PIC/S and quality domestic pharmaceuticals to the world. MFDS has also requested the listing of Korea in EU's whitelist (exempt from having to provide written confirmation of compliance for APIs exported from the country). MFDS submitted the application in January 2015 and is currently awaiting EU's approval.
2) Stabilization of Internationally Harmonized GMPs for Korea
To harmonize Korean GMP with PIC/S GMP, MFDS made necessary changes to relevant regulations and standards.
In Aug. 21, 2014, the 「Regulation on the Safety of Pharmaceuticals, etc.」 was revised and promulgated (July 1, 2015). Its main contents are ▲Introduction of the validation system on herbal medication and post-release stability tests on drug products, ▲Development of separate standards on pharmaceuticals for clinical trials and the APIs that were regulated by the GMPs of drug products, ▲Introduction of new GMPs for radioactive medicine and medical high-pressure gas. In addition, the 「Regulation on the Safety of Pharmaceuticals, etc.」 was revised on Oct. 10, 2014 to introduce the “GMP Compliance Certification System”. With this system, a 3 year expiration date was set up to the evaluation result of GMP for manufacturers so that evaluation can be carried out regularly. So, by changing the system for pharmaceutical quality control from ‘quality control at pharmaceutical approval stages’ to ‘quality control after sales’, a foundation for supplying quality-assured medicine was established.
Also, the ｢Regulation on Good Manufacturing Practices (GMP)｣ which reflects the 16 annexes of the GMP regulations established by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) was enacted in June, 2015, and implemented in July. MFDS also held seminars to stably establish the new GMPs for medical, high-pressure has and radioactive pharmaceuticals and also established the field administrative support system in January 2015 at MFDS and 6 of the regional offices of food and drug safety to provide guidance to and gather feedbacks from the manufacturers implementing GMPs.
C. Implementation Plan
For continuous international harmonization of GMP regulations, MFDS plans to establish a public-private consultative body with the pharmaceutical industry, periodically review PIC/S' GMP Guide revisions, apply them to Korean GMP regulations and if possible, share PIC/S' GMP revisions with the pharmaceutical industry. In 2016, MFDS will apply PIC/S' GMP Guide Part 1 (Guide to GMP for Medicinal Products) and GMP Annex 15 which describes the principles of qualification and validation used for the manufacture of medicinal products into Korean GMP guidelines.
Based on the improved country rating of Korea after joining the PIC/S, MFDS will hold the 2nd Korea-ASEAN. Pharmaceutical GMP Cooperation Conference to promote Korean pharmaceutical companies’ overseas business. Many advanced PIC/S member states such as the US and European countries have recently become more serious on strengthening the management of the manufacturing facilities for beta-lactam antibiotics which often cause hypersensitivity reactions. To reduce the risk of cross-hypersensitivity and to create a safe pharmaceutical environment, MFDS plans to make it mandatory to separate the processing facilities for carbapenem antibiotics and monobactam antibiotics as the international guidances for beta-lactam antibiotics facility suggest. Also, for those companies having difficulties in introducing GMPs for radioactive drugs and medical, high-pressure gas, MFDS will provide administrative field support through the GMP Administrative Support System. MFDS will also share useful information about GMPs and provide guidance by holding seminars in 6 regional offices of drug and food safety.
Kim Ki-man, Director of Biopharmaceutical Quality Management Division ☎ 043.719.3651 |
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发表于 2019-8-18 08:28:32
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