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International Regulatory Harmonization

Regulatory harmonization represents a process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products. Harmonization of regulatory requirements has many benefits such as ensuring favorable marketing conditions to support early access to medicinal products, promoting competition and efficiency, and reducing unnecessary duplication of clinical testing.

FDA engages with stakeholders globally through international venues to respond to the increasingly complex and global nature of pharmaceutical industry operations and related regulatory oversight. This work progresses FDA’s mission by ensuring pharmaceutical safety and effectiveness and is accomplished through FDA’s involvement in several international organizations including the International Council for Harmonisation (ICH), International Pharmaceutical Regulators Programme (IPRP), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Asia-Pacific Economic Cooperation (APEC), and International Coalition of Medicines Regulatory Authorities (ICMRA).

International Council for Harmonisation

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international nonprofit association that brings regulatory authorities and pharmaceutical industry together to harmonize scientific and technical aspects of drug registration. ICH's mission is to achieve greater harmonization to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. This work is accomplished through the development of internationally harmonized Guidelines in the areas of Safety, Efficacy, Quality, and Multidisciplinary topics. International harmonization leads to improved efficiency in the regulatory review process, reduced time to get a product to the market, reduced patient burden through prevention of unnecessary duplication of clinical trials and post market clinical evaluations, and reduction of unnecessary animal testing without compromising safety and effectiveness.

FDA has participated in ICH as a Founding Member since 1990 and implements all ICH Guidelines as FDA Guidance. FDA encourages implementation of ICH Guidelines by pharmaceutical regulatory authorities globally.

International Pharmaceutical Regulators Programme (IPRP)

The International Pharmaceutical Regulators Programme (IPRP) was established on January 1st, 2018 as a result of the consolidation of the International Pharmaceutical Regulators Forum (IPRF) and the International Generic Drug Regulators Programme (IGDRP). The membership of IPRP is comprised of representatives from pharmaceutical regulatory authorities and organizations, with a responsibility for the regulation of medicinal products for human use, that wish to participate. IPRP was created to establish a forum for its members and observers to exchange information on issues related to regulation of pharmaceutical medicinal products for human use and to promote regulatory convergence. IPRP provides a multilateral forum for FDA to engage with other pharmaceutical regulatory authorities to address the increasingly complex global nature of pharmaceutical regulation, advance regulatory harmonization projects, promote regulatory best practices, and better understand opportunities that may exist for international harmonization under other venues such as ICH.

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 52 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia). PIC/S aims at harmonizing inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors.

PIC/S also aims at facilitating co-operation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence. This is reflected in PIC/S’ mission which is to lead the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates in the field of medicinal products. This is to be achieved by developing and promoting harmonized GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates and facilitating the co-operation and networking for competent authorities and international organizations.

FDA became a Member of PIC/S in 2011, serves on the PIC/S Steering Committee and provides leadership and technical contributions in many of the PIC/S Work Groups and Expert Circles.

Asia-Pacific Economic Cooperation (APEC)

APEC is a regional economic forum established in 1989 to leverage the growing interdependence of the Asia-Pacific region. APEC's 21 member economies aim to create greater prosperity for the people of the region by promoting balanced, inclusive, sustainable, innovative and secure growth and by accelerating regional economic integration.

FDA participates in the Regulatory Harmonization Steering Committee (RHSC) under the auspices of APEC’s Life Sciences Innovation Forum (LSIF). The RHSC focuses on developing tools and delivering training on drug regulatory best practices and internationally harmonized guidelines such those developed by ICH and the World Health Organization (WHO). The RHSC's objective is to enable regulatory authorities in the APEC regions and beyond to implement regulatory best practices and increase regulatory harmonization, improving drug product safety and quality globally.

The APEC RHSC currently conducts work in six priority areas including:

  • Multi Regional Clinical Trails and Good Clinical Practices Inspections
  • Pharmacovigilance & Medical Device Vigilance
  • Biotechnological Products
  • Cellular Therapies
  • Good Registration Management
  • Global Supply Chain Integrity

In addition, the RHSC has established APEC Training Centers of Excellence for Regulatory Science (COEs) to promote regulatory convergence, capacity, and cooperation in topic areas relevant to medical product regulation. The COEs are located in various APEC regions and develop and provide training programs based on internationally harmonized standards where the RHSC provides input on core content and training objectives. The COE model is intended to be self-sustaining.

International Coalition of Medicine Regulatory Authorities (ICMRA)

ICMRA is an executive-level forum of medicines regulatory authorities that works to:

  • Provide strategic coordination, advocacy and leadership
  • Address current and emerging human medicine regulatory and safety challenges globally
  • Provide direction for areas and activities common to many regulatory authorities' missions
  • Identify areas for potential synergies

CDER participates in ICMRA and supports its strategic initiatives including pharmacovigilance, supply chain integrity, innovation, crisis management, and regulatory communication and information sharing.

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