Narrowing the regulatory gap via system strengthening and harmonization

Regulatory harmonization enables both regulatory authorities and our industry to pursue a shared commitment to protect public health.

Patients in all countries have a fundamental right to receive medical products meeting global standards of quality, safety, and efficacy. Development of globally harmonized guidelines and requirements contributes to meeting this expectation.

Over the past decades, regional mechanisms, working towards the harmonization of regulations across national boundaries have been developed in most continents (Europe, Asia, Africa, Latin America). Efforts built on adapting the International Council of Harmonization (ICH) pioneering harmonization work, or leveraged the use of the World Health Organization (WHO) requirements for the development, manufacture, and control of Active Pharmaceutical Ingredients (API) and Finished Pharmaceutical Products (FPP).

We support the growing number of global regulatory networks, as well as the expansion of linkages between harmonization initiatives, aimed at strengthening regulatory systems. Our industry expertise contribution to developing harmonized norms and standards that enable an adequate quality, safety, and efficacy control of medical products globally is critical. Based on public heath objectives, and through a longstanding collaboration with ICH, WHO, National Regulatory Authorities and global regulatory stakeholders, we are a strong advocate for unified quality, safety, and efficacy standards to medical products, and for continued support to countries in need.

We play a facilitating role in providing national regulatory authorities and key stakeholders with positions to inform the development of coherent, converging, and efficient science-based regulatory policies. We are actively involved in promoting best regulatory practice sharing through the organization of regulatory platforms that focus on addressing key regulatory hurdles that hamper patients’ timely access to innovative therapies.

Manufacturing

An appropriate level of regulatory oversight through continued international cooperation can facilitate the best use of national regulatory authorities and industry resources to optimally control the quality, safety, and efficacy of medical products for patients’ benefit.