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Regulatory Harmonization and Convergence

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: Supply Chain Integrity and Product Quality, Pharmacovigilance, Good Review Practices, Multi-regional Clinical Trials, Good Clinical Practice Inspection, Cell and Tissue-based Therapeutic Products, and Biotherapeutic Products.

International Council on Harmonisation (ICH)

ICH was, until recently, known as the International Conference on 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 on 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.

International Medical Device Regulators Forum

The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. It 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 to accelerate international medical device regulatory harmonization and convergence. The current members as of 2015 are: Australia, Brazil, Canada, China, Europe, Japan, Russia, and the U.S. The World Health Organization and the APEC LSIF Regulatory Harmonization Steering Committee are Official Observers. The Asian Harmonization Working Party and the Pan American Health Organization are IMDRF Affiliate Organizations.

IMDRF is primarily an engagement of FDA’s Center for Devices and Radiological Health (CDRH), however because CBER also regulates certain devices, it participates through CDRH to assure our interests are represented. CBER regulates devices such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood and cell products or to ensure the safety of the blood supply.

The International Pharmaceutical Regulators Forum (IPRF)

The IPRF was formalized in 2013. At that time an official mandate and Terms of Reference were established which built upon the foundation of the Regulators Forum, the antecedent group to the IPRF. The underlying intent of both fora has been to provide a “safe harbor” for regulator-only discussions. The IPRF meetings have historically been held in conjunction with the International Conference of Harmonisation (ICH) meetings for the sake of efficiency, but it is completely independent of ICH. The goals of IPRF are: to enable all parties to identify new approaches and specific best practices, and develop smart strategies for dealing with the challenges of a rapidly evolving globalized pharmaceutical industry; to provide a global overview of the different regulatory developments at national and international level and enable open sharing of information and ideas among regulatory leaders with hands-on operational responsibilities; and to support international regulatory cooperation in areas which are not covered by existing initiatives. As of 2016, five working groups had been established specific to: Gene Therapies, Cell Therapies, Good Clinical Practices (work completed), Biosimilars, Nanomedicines and Identification of Medicinal Product Standards (IDMP). CBER joins the Center for Drugs Evaluation and Research (CDER) as members of the IPRF.

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 the CDER, the CDRH, the Office of Regulatory Affairs and the Office of International Programs in the Office of the Commissioner.

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