International Harmonization
International Harmonization
Codex Alimentarius Commission (CODEX)
- Founded in 1962, the Codex Alimentarius Commission (CAC) is the body established by Food and Agricultural Organization (FAO) and World Health Organization (WHO) under the Joint FAO/WHO Food Standards Programme. It coordinates input from 187 Member Countries and one Member Organization to develop and endorse the international food standards that comprise the Codex Alimentarius. Its role is to establish a broad range of international food safety and quality standards, codes of practice, and guidelines for use by its member countries, which are either taken up in national legislation or referred to in setting national food laws to ensure the safety of food supply and to promote trade in food.
- Since 1971, the Republic of Korea has been a member of Codex and actively participated in the work for harmonizing national food standards with Codex standards. The Codex standards of Korean traditional foods such as Gochujang, Ginseng and laver products were established in 2009, 2015 and 2017, respectively. Not only participating in the meeting but also the ROK had been nominated as a Coordinator of FAO/WHO Coordinating Committee for Asia (CCASIA) from 2003 to 2007. Currently, the ROK (MFDS) has been hosting Ad hoc Codex Inter-governmental Task Force on Antimicrobial Resistance (TFAMR) since 2017 and is taking the leading role in efforts to reduce antimicrobial resistance. To support developing countries to participate in Codex works, the MFDS starts delivering Codex Trust Fund to the WHO from 2020. Every year, the MFDS actively participates in the meeting of each Codex Committees (approximately 10 to 13 meetings including the CAC) and delivers comments in paper or in person at the venue.
International Coalition of Medicines Regulatory Authorities (ICMRA)
- At the 7th Heads of Medicines Regulatory Agencies Summit held in December 2012 at Manaus, Brazil, the heads reached an agreement to establish the International Coalition of Medicines Regulatory Authorities (ICMRA) with an aim to address medicinal issues.
- Launched in 2014, the ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to:
- address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner
- provide direction for areas and activities common to many regulatory authorities' missions
- identify areas for potential synergies and
- wherever possible, leverage existing initiatives/enablers and resources
- Since the 7th Summit in 2012, the MFDS has been participating in the ICMRA annual meeting to share regulatory information and discuss cooperative measures with the international regulatory authorities. Also, based on mutual trust between regulatory authorities and MFDS, the MFDS has been holding bilateral meetings for cooperative activities such as information exchange, work sharing, capability enhancement support, which strengthen international cooperation in holding joint workshops, signing an Agreement on Mutual Reliance of GMP and Confidentiality Agreement, among others.
International Council for Harmonisation (ICH)
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was formed in 1990 to bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. The ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.
- The MFDS joined the ICH as a Regulatory Member in 2016 and was elected as a member of Management Committee in 2018. The ICH prepares guideline based on each regulatory authority’s comments after further discussions by the ICH Working Groups which consist of regulatory authorities and industries. The MFDS engaged in 16 areas of the 34 existing ICH Working Groups.
- The MFDS distributed Korean version MedDRA in 2019 and has been test-operating the KAERS (Adverse Reaction Reporting System) by including the Korean version MedDRA. Additionally, the MFDS has been conducting the annual education program regarding the areas that are likely to show high demand, including the enacted and revised guidelines, for the pharmaceutical industry.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 53 Participating Authorities coming from all over the world.
- PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. This is reflected in PIC/S’ mission which is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products.
- The MFDS has been a member of PIC/S since July 2014, and has attended the PIC/S Committee Meeting and various events such as PIC/S annual seminar, PIC/S Expert Circles, and Joint Visit Program (JVP).
- MFDS has also participated as a member of Sub-committee on Training (SCT) to coordinate and monitor all the PIC/S training activities along with other member of SCT. Besides, MFDS continues to implement the PIC/S standards by communicating with pharmaceutical industries, providing training programme for GMP inspectors on updated PIC/S GMP guidelines, and revising the domestic laws and regulations.
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International Medical Device Regulators Forum (IMDRF)
- Conceived in 2011, the IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.
- The IMDRF Management Committee, composed of regulatory officials, provides guidance on strategies, policies, directions, membership and activities of the Forum. Furthermore, the Management Committee oversees Working Groups, which draw upon expertise from various stakeholder groups such as industry, academia, healthcare professionals, consumer and patient groups.
- The Republic of Korea joined the IMDRF as its 10th member state in December 2017, serving as a member of the Management Committee (MC), and working on the enactment and revision of international guidelines by participating in 13 Working Groups operated by the IMDRF. In particular, since South Korea has been named Chair (March 2019) of the IMDRF in 2021, it will play a leading role in the overall IMDRF activities including the hosting of the IMDRF regular general assembly (two times in the first and second half). Furthermore, it plans to strengthen its role as an advanced country in medical devices by newly establishing and adding a Working Group on “AI Medical Devices” to the current 13 Working Groups (5 groups closed).
