by José Luis Cárdenas Tomažič

Adapted from the Spanish column originally published in El Economista on April 4th, 2024 (Convergencia y Armonización Regulatoria: Claves para el Acceso Global a Medicamentos)

In the complex landscape of public health, the need to access diverse therapeutic alternatives continues to grow. These alternatives come from both local and imported sources, all of which must obtain marketing authorization prior to commercialization and use by health systems and, ultimately, by patients.

In this context, pharmaceutical companies seeking to launch their medicines in different markets frequently face varying regulations. This requires multiplying efforts to comply with diverse regulatory requirements in each country where they intend to commercialize their products (what we will refer to as “regulatory divergence”).

This can increase the costs and timelines required to bring a medicine to market, without necessarily resulting in higher levels of quality, safety, or efficacy. There is limited research on the economic impact of regulatory divergence; however, one study estimated that it is equivalent to a 19% tariff when comparing regulatory differences between the United States and the European Union.

For this reason, regulatory convergence and harmonization in the pharmaceutical field emerge as essential foundations for ensuring equitable and safe access to quality medicines worldwide. These processes not only simplify the registration and commercialization of medicines but also promote efficient use of resources and avoid unnecessary duplication of clinical studies, in line with the ethical principles of clinical research. Minimizing regulatory divergence is the basis for implementing a “Single Global Development” of a medicine, whereby the clinical and technical data supporting marketing authorization are accepted across most regions by various regulatory agencies.

Precisely in this direction, the World Health Organization (WHO) has played a crucial role, serving as a guide and coordinator for countries in harmonizing pharmaceutical regulations. Through international agreements, guidelines, the prequalification system, among others, WHO promotes quality and safety standards that are essential for safeguarding global public health. However, real progress is achieved through the joint action of national regulatory agencies.

A key initiative in this regard is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Established in 1990, ICH brings together regulators and the pharmaceutical industry to develop common technical guidelines that streamline the drug registration process without compromising safety or efficacy.

Another fundamental pillar has been the Common Technical Document (CTD). As an international standard adopted by the ICH, the CTD establishes a harmonized format for submitting technical information on medicines. This simplifies regulatory review by providing a consistent and uniform framework for evaluating quality, safety, and efficacy.

Similarly, the International Pharmaceutical Regulators Programme (IPRP) and the International Coalition of Medicines Regulatory Authorities (ICMRA) have served as platforms that facilitate communication and cooperation among regulators, promoting regulatory convergence and the adoption of best practices worldwide. Also noteworthy is PIC/S (Pharmaceutical Inspection Co-operation Scheme), an international organization that promotes the harmonization of standards and procedures in the inspection of manufacturing facilities.

In Latin America, the Pan American Network for Drug Regulatory Harmonization (PANDRH) has also played a significant role. It facilitates regional cooperation to harmonize pharmaceutical regulations, thereby promoting the efficacy and safety of medicines in the region.

A notable example of the importance of regulatory harmonization is the case of biosimilars. In this area, there has been increasing regulatory convergence, which has facilitated the evaluation and approval of biosimilars across different countries, accelerating their market entry and improving patient access. In this regard, the WHO’s 2022 Guidelines on the Evaluation of Biosimilars are particularly relevant, although they still need to be adopted and implemented by many countries.

In addition to harmonization, mechanisms such as mutual recognition and reliance play a crucial role in facilitating access to medicines. These allow regulators to rely on the assessments and decisions of trusted regulatory authorities, thereby expediting registration processes and reducing duplication of efforts.

Despite all these benefits, there is still a long way to go to achieve greater global regulatory convergence and harmonization. Several factors may contribute to this process, while others act as barriers, including the varying levels of maturity of national regulatory agencies, the resources available to implement these processes, and even geopolitical considerations.

As can be seen, there is a clear need for greater regulatory convergence and harmonization in the pharmaceutical sector to ensure equitable and safe access to medicines worldwide, ultimately benefiting patients. It is therefore essential to continue advancing these efforts, learning from what has worked so far, exploring new solutions, and avoiding—whenever possible—those factors that have hindered progress.