Gloria Frías
RAF Consulting
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New Norms Require Better Pharmacovigilance

By Jan Hogewoning | Sun, 12/29/2019 - 10:00

Q: You are active in different areas. Which are your strongest?

A: Our expertise is the regulatory segment related to medication and medical devices. What makes us unique is that we have a true understanding of the needs of the commercial areas. Those who contact us tend to be companies that are starting business in Mexico and needs to understand what is required to sell their products in. About 60 percent of our clients are foreign companies, which need certainty and a clear path to deal with regulations in Mexico. We help with the complete process from defining a strategy, registering their product, compliance and due diligence, and also provide postmarketing support. We can act as the titleholder of products on registration for companies without a physical presence in the country. We also provide advice in other areas like advertising, GMPs requirements and pharmacovigilance and techno-vigilance.  We also help connect companies with other entities to achieve shared goals. Our clients find us mainly through recommendations. Our greatest demand comes from manufacturers of medical devices, and pharmaceutical laboratories.

Q: What are the principal challenges faced by foreign companies in Mexico?

A: The authorities in other countries, for example, Europe provide clear information regarding regulations. In Mexico, there is less clarity. What is surprising to many foreign companies is that Mexican regulation is often more demanding than their international counterparts. At the moment, the regulatory environment is even more complicated by changes in the way COFEPRIS operates. There have been some  changes mainly regarding criteria interpretation by the new government. as a consequence of a lack of clarity in the current regulatory panorama, we are committed to apply stricter standards to our work and services assuring customers have the most robust strategies and successful results. The lack of clarity about the government’s rules has led to many foreign companies canceling projects. They usually have a limited budget to invest in new projects, and sadly, currently Mexico is not becoming the country of choice.

Q: You offer flexible services. What does this entail?

A: Many companies have their own established procedures with which they want to work. We have the flexibility to adapt our services to our clients’ needs and requests. For example, we can take a single small project or be the regulatory affairs department of a company, we can help also to regulatory areas of stablished companies when they have a work overload. We have different levels of service and we are flexible enough to adapt to any of the clients´ needs, we want to be at the top of their mind when they need regulatory supplies.

Q: What services do you provide in the area of pharmacovigilance?

A: Our service in pharmacovigilance is guided by norm 220. There are basically two different kind of pharmacovigilance. One is passive pharmacovigilance, where we receive information about adverse effects of medical products from patients, doctors and hospitals through a call center and we report this to the laboratory or COFEPRIS, depending on the agreement we had with the laboratory. Conversely, a laboratory can pass information to us and then we pass this to the patients, doctor or hospital, to be available for any information request. The information on adverse effects of a medication is reported to COFEPRIS through a specific procedure. The other service is active pharmacovigilance. In this case, we push to get information directly from a doctor or clinic and obtain specific information about the adverse effects of a medication. We can also generate some information and specific documents required to comply with the norms such as operation standard procedures, risk management plans, active pharmacovigilance programs, periodic reports or technovigilance reports, among others.

The challenge is to get the information that the authorities require. We have a call center that operates in this area obtaining and providing information in a coordinated way assures regulatory compliance.

Q: You also offer generation of risk management plans. What do these entail?

A: The first stage of implementing a risk management plan is to create an extensive document that describes all the potential risks of a medical product, this might be known or unknown This is done by collecting clinical and safety information, about the medication and the illness involved. On the basis of this, all the possible risk factors are identified and a plan is established to minimize these risks. This plan often includes communication to doctors and patients and an active pharmacovigilance program. To give you an example, there are certain products that should not be taken by pregnant women because they may pose a threat to the development of the baby. The risk management plan  would then be focused on ensuring that those individuals taking the medication are not pregnant. This can be done by mandating that the doctor conducts continuous pregnancy tests of the patient and that the person commits to using contraceptives. These plans were at first only requested for new products. However, with the new norm, they are now mandatory for all products, including generics.  

Q: What are your principal goals for 2020-2021?

A: We want to be the consultant of choice for companies looking for an integrated service. We are optimistic as we believe that changes in regulatory norms will require greater expertise in the regulatory and pharmacovigilance areas. As norms become stricter, a more profound understanding of the regulations and authority´s work becomes more necessary to advice clients in the best way to comply with them.

We would like to continue growing have more clients among the pharmaceutical labs in Mexico. Lastly, we will continue to attempt to understand the regulatory situation in this country as the government makes new moves. The goal is to provide as much certainty to our clients as we can.



RAF Consulting provides regulatory consultancy for health sector companies. Its services include solutions for regulatory affairs, registration of medications and medical devices, pharmacovigilance and techno-vigilance. The company has broad experience working with foreign companies interested in selling their products in Mexico. 

Jan Hogewoning Jan Hogewoning Journalist and Industry Analyst