Regulatory Harmonization and Convergence
The term “regulatory harmonization” can have different definitions depending on the context of its usage. One definition that is applicable to those efforts CBER is involved with is: the process by which technical guidelines are developed to be uniform across participating authorities. “Regulatory convergence,” on the other hand, represents a process whereby the regulatory requirements across countries or regions become more similar or “aligned” over time as a result of the gradual adoption of internationally recognized technical guidance documents, standards and scientific principles, common or similar practices and procedures, or adoption of regulatory mechanisms that might be specific to a local legal context but that align with shared principles to achieve a common public health goal. It does not necessarily represent the harmonization of laws and regulations, which is not a prerequisite for allowing the alignment of technical requirements and greater regulatory cooperation. The Agency engages in a range of explicit harmonization initiatives as well as convergence activities, a number of which include the participation of CBER.
CBER Harmonization Program Activities
Asia-Pacific Economic Cooperation Life Sciences Innovation Forum Regulatory Harmonization Steering Committee
The Asia-Pacific Economic Cooperation (APEC) organization is a multilateral, voluntary collective of economies that border the Pacific. APEC promotes trade and sustainable economic growth through policy alignment and technical cooperation. APEC undertakes its work through an array of dedicated subject matter fora, which includes the Life Sciences Innovation Forum (LSIF). The primary goal of the LSIF “is to bring together representatives of the government, private sector and academia to promote life-sciences innovation in support of human health in the region.” In 2008, the Regulatory Harmonization Steering Committee (RHSC) was created under the authority of the LSIF in order to promote a strategic and coordinated approach to medical product regulatory harmonization/convergence and capacity building efforts within the APEC region. The RHSC has developed a Strategic Framework that identifies priority work areas and implementation roadmaps which promote greater convergence in the regulation of medical products, which includes training as an important component. FDA CBER joins the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health in participating in the RHSC and its working groups. FDA CBER experts contribute to the following priority work areas: Global Supply Chain Integrity and Product Quality, Pharmacovigilance, Good Registration Management, Multi-regional Clinical Trials and Good Clinical Practice Inspection, Advanced Therapies, Medical Devices, and Biotherapeutic Products.
International Council for Harmonisation (ICH)
ICH was, until recently, known as the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. However, as of October 23, 2015, it became an Association under Swiss Law upon the finalization of the Articles of Association. With this change, ICH became the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Also, ICH changed its governance structure, funding model, and opened its doors to new members to widen its global reach.
ICH stands as the seminal initiative in the domain of regulatory harmonization for medical products. The primary objective of ICH is to promote public health. The aim is to contribute to a more timely introduction of new medicines and continued availability of approved medicines to patients. For example, by minimizing the use of animal testing and preventing unnecessary duplication of clinical trials in humans, without compromising safety and effectiveness, as well as contributing to the development, registration and manufacturing of safe, effective and high quality medicines in an efficient and cost-effective manner. Moreover, it works to fulfill this goal through the development of harmonized guidelines through a process of scientific consensus by regulatory and industry experts. Furthermore, a key ingredient to the success of the ICH is the commitment by its regulatory members to implement its guidelines. Thus, finalized ICH guidelines are implemented in the U.S. as FDA guidances through its usual Federal Register publication process.
The International Pharmaceutical Regulators Programme (IPRP)
The International Pharmaceutical Regulators Programme (IPRP) was officially launched on 1 January 2018, following a decision of the governance bodies of the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF) in November 2017. The two initiatives had complementary objectives and a largely overlapping membership of regulatory authorities and organizations, but covered a different scope of products: IPRF focused on innovative pharmaceutical products and technologies, IGDRP focused on issues of interest relating to generic products. Both sides had agreed that by a consolidation of the two initiatives, efficiencies could be gained and synergies be created.
The IPRP strives to create an environment for its members and observers to exchange information on issues of mutual interest and enable cooperation among regulatory authorities and organizations, maximize synergies and avoid duplication of effort, create a regulatory hub for pharmaceuticals, and enable closer linkages with other initiatives to, again, maximize synergies and avoid duplication of effort.
The IPRP meetings are held in conjunction with those of the International Council for Harmonisation (ICH) in the interest of efficiency. The ICH Secretariat provides support services to IPRP through funding provided by a number of the IPRP members, including the FDA.
The former working groups of the IPRF and the IGDRP continue to operate. CBER experts are active in the Gene Therapies Working Group, the Cell Therapies Working Group, and the Identification of Medicinal Product Standards (IDMP) Working Group. CBER joins the Center for Drugs Evaluation and Research (CDER) as members of the IPRP MC.
A new website was created for the consolidated initiative under the domain name www.iprp.global where general information on the IPRP can be found as well as information and the work products of the various working groups.
Pan American Network for Drug Regulatory Harmonization
The Pan American Network for Drug Regulatory Harmonization (PANDRH) is an initiative of the National Regulatory Authorities of the region and the Pan American Health Organization that supports the processes of regulatory convergence/harmonization in the Americas, within the framework of national and sub-regional realities, needs, laws and policies related to health. The PANDRH comprises:
The Pan American Conference on Drug Regulatory Harmonization, the Steering Committee, the Advisory Council and the Technical Groups in as many areas as defined by the Conference and the Secretariat to be a priority. Its mission is to advance regulatory convergence in the arena of health products covering aspects of quality, safety, effectiveness and rational use of health products, and the strengthening of the capacities of the National Regulatory Authorities (NRAs) in the region of the Americas, based on the needs of the population to have access to quality health products in accordance with the progress of science and technology within the context of national and sub-regional realities. CBER participates in partnership with other components of the Agency.