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Regulatory News | 14 February 2018 | By Zachary Brennan
Aligning pharmaceutical and medical device regulations across Latin America has been a priority over the past several decades, and though there has been some progress, Rafael Pérez Cristiá, director of the Havana, Cuba-based Center for State Control of Medicines, Equipment and Medical Devices (CECMED) explains in an interview with Focus that regulatory harmonization has seen its fair share of speed bumps.
Below are Cristiá’s answers to Focus questions, submitted and answered via email (in English and translated into Spanish below the English), with some light edits.
Focus: Which countries in Latin America lack the regulatory capacity of some of their largest peers (i.e., Brazil and Argentina) and is there a desire that these smaller countries align more with their peers?
Cristiá: In Latin America there is a broad asymmetry of regulatory frameworks in different countries, which is more accentuated for medical devices. An important effort to strengthen the regulatory systems of medicines and medical devices in the region has been a current goal of many countries and the Pan-American Health Organization/World Health Organization (PAHO/WHO) to guarantee access to quality medicinal products.
To this end, the Directing Council of PAHO approved Resolution CD50.R9, resulting in the strengthening of the National Regulatory Authorities (NRAs) and recognizing the initiative of the Member States and PAHO/WHO under an agreement for the preparation of an instrument to evaluate NRAs.
The process of evaluation and qualification of NRAs is based on the verification of indicators contained in a data collection tools based on recommendations of the WHO for the strengthening of the regulatory bodies, which establishes four levels of development, with Level IV designated by PAHO/WHO as regulatory authorities of regional reference.
As of January 2018, the following National Regulatory Systems have been pre-evaluated or evaluated across the Latin American region: Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panamá, Paraguay, Perú, Dominican Republic and Venezuela. As a result of this process, PAHO has designated as regulatory authorities of regional reference (as per Resolution CD50.R9) the following regulators:
- Argentina - National Administration of Medicines, Foods and Medical Technology (ANMAT)
- Brazil - National Health Surveillance Agency, Ministério da Saúde (ANVISA)
- Chile – Institute of Public Health (ISP)
- Colombia - National Institute for Drug and Food Surveillance (INVIMA)
- Cuba - CECMED
- Mexico - Federal Commission for the Protection against Sanitary Risks (COFEPRIS)
The results achieved have allowed other Latin American countries to evaluate and utilize the PAHO/WHO evaluation tool to help analyze their own qualifications to further strengthen the capacity of their own regulatory body while gaining direct benefit from the processes and information derived from the national regulatory reference authorities. Following this path has helped overcome existing differences, also allowing other authorities with fewer capacities to have the necessary elements in order to make the most appropriate decision regarding a medicinal product.
Focus: What are some of the types of regulations that could potentially be harmonized in the future?
Cristiá: The processes of harmonization of pharmaceutical regulation between countries has been aimed at finding a common basis of regulations in order to reduce unnecessary duplication of regulatory requirements and to facilitate faster market access at lower costs.
The harmonization of pharmaceutical regulation is a complex process that requires time, knowledge and collective experience. However, the need to improve access and to facilitate trade with full adherence to the required safety, effectiveness and quality requirements has been the main motivation for global harmonization systems initiatives such as the International Conference of Authorities Regulators of Medicines (ICDRA/OMS), the International Council on Harmonisation (ICH) and the Pan American Network for the Harmonization of Pharmaceutical Regulation (PARF Network PAHO/WHO).
The above harmonization initiatives have served as the premise for the PAHO to convene the First Conference of the Pan American Network for the Harmonization of Pharmaceutical Regulation (PARF Network) in 1997 with the participation of drug regulatory authorities of the PAHO member states, the pharmaceutical industry, generic manufacturers, academia, consumer organizations; professional associations from the health sector and other interested groups.
Since its creation, the PARF Network has created documents in compliance with PAHO Resolutions based on the needs of the countries of the Latin American region and also supporting regional technical cooperation initiatives to strengthen capacities of the national regulatory authorities.
Over the last 20 years, the PARF Network Working Groups have addressed issues consistent with pharmaceutical harmonization in the region of the Americas with results drafted and published in 12 technical documents related to topics of high significance, such as: "Harmonized requirements for the registration of vaccines in the Region of the Americas and Guide for the preparation of an application for sanitary registration," "Good Pharmacovigilance Practices for the Americas," "Recommendations for the Evaluation of Similar Biotherapeutic Products," and "Requirements for the registration of medicines in the Americas," among others.
Despite the lack of harmonization in drug regulation in the different Latin American countries, the PARF Network technical documents that have been harmonized across the countries of the region have not yet been implemented, as expected, within each regulatory frameworks.
It is my opinion that regional harmonization efforts in the future should be aimed at converting the PARF Network technical documents into national regulations in order to guarantee an effective implementation.
Cristiá: Mainly, the differences in the political and health realities, together with the legislations of each country of the region. In many countries, there is a lack of a functional system for pharmaceutical regulation, the lack of technical competence by professionals holding positions within the regulatory authorities and from the national pharmaceutical industry side, a lack of implementation due to the high scientific and technical standards of compliance.
The high costs for implementing harmonized regulations may also be difficult and not easy for some countries to take on.
Focus: How often do the different regulators interact and correspond to the problems that arise in their respective countries (i.e. adverse events, medicine withdrawals, etc.)?
Cristiá: The exchange of information between regulatory agencies is very important and it’s imperative to respond to the multiple and complex problems that arise related to the manufacture, trade and use of medicines and to ensure the protection of health.
A strategic objective of the PARF Network is to promote the exchange of information, knowledge and experiences aimed at strengthening the regulatory capacities of countries and facilitating the exchange of information among the NRAs to strengthen the decision-making process when regulating new and complex health technologies.
Therefore, speeding up the exchange of regulatory confidential information, using the Regional PRAIS/PAHO Platform has turned into a valuable source and mechanism identified by the regulators as a priority for the Latin American health authorities.
Even though multiple efforts and different initiatives have been implemented or are underway to achieve better communication and exchange of information among the regulators across the Latin American region, these efforts are not yet sufficient or as effective as they should be, and there is still a long way to go.
It is necessary to continue promoting an active and committed participation of regulators, as well as a cooperation between countries to strengthen regulatory capacities in an effort to increase the safety levels of medicinal products for the population.
We need to establish mechanisms to favor national and international regulatory convergence and greater confidence in the decisions adopted by other competent authorities in order to achieve greater efficiency in the use of resources to favor faster access to safe and effective essential medicines.