Joint review of medicines in Central America
The Joint Evaluation of Drug Records is a mechanism by which individuals or corporations may request the technical assessment of medicinal products for human use, for applications for a new Health Register.
This was the topic of the webinar conducted by the Pan American Health Organization (PAHO) on May 27th, with the participation of Analía Porras, PAHO representative, Leonardo Sánchez, director of pharmaceutical products of the Honduran Health Regulatory Agency (ARSA), and José Vicente Coto, national director of medicines of El Salvador.
What is it?
This mechanism brings together various regulatory specialists from Central America, integrated into a commission in which the drug records are verified, evaluated, and qualified, through a legal technical process that ensures that the evaluated drug complies with the technical regulations of the region.
By applying this mechanism, a single technical opinion is obtained, which can be attached to the health register process of each participating country, ensuring an expedited procedure. In addition, “this mechanism draws attention to the easy access and reduction of times”, as Leonardo Sánchez recounted, emphasizing that the request is made through the ARSA website.
Participants in this mechanism are countries of the Central American region: Honduras, Costa Rica, El Salvador, Guatemala, the Dominican Republic, and Panama, which seek to contribute to the regulatory strengthening of the region, as they bring countries closer in an effort to integrate the processes and criteria for evaluating drug records that are in the process of accessing the market.
Given the costs, the process of joint review of a new medical record of drugs will be free in the initial phase. For its part, the application for the register procedure in the different countries will be subject to the tariffs of each State, since each country retains its legal autonomy as regards the issuance of the health register.
In this regard, this mechanism is based on Central American technical regulations as a legal reference. However, each country maintains its autonomy in terms of evaluation and opinion for the issuance of the health register.
Thus, the outcome of the joint evaluation means a consensus view on each drug, based on common observations from the review countries and, “in the event of a lack of agreement, countries have agreed to enter into a process in which this is resolved, so that a sole opinion comes out,” as José Vicente Coto put it. This consensus opinion continues with the corresponding administrative process of the health register of each country.
In general terms, this mechanism aims to standardize the technical review process, bringing together different regulatory specialists from the region, who provide their opinion on the drug individually and thus, a single opinion is subsequently generated.
In this way, “this mechanism is conceived as an opportunity to bring countries closer together, promoting the approval of criteria to evaluate an application,” as the ARSA Director of Pharmaceutical Products explained, since each country has its strengths, and this mechanism seeks to copy the strengths of each and to grow together as a region.
In addition, this will favor the optimization of the processes and represents a step forward, as Analía Porras said: “for almost a year, we have been working with the authorities to build an efficient, transparent and appropriate process for the region. Despite the pandemic, we have made a lot of progress”.