Fidel Martínez belongs to the Regulatory Affairs department at Asacpharma. This department is responsible for ensuring that products, whether they are pharmaceuticals, medical devices, cosmetics or food supplements, comply with all regulations and legal requirements before they are marketed. Its main function is to manage the documentation necessary to obtain regulatory approvals, interact with agencies such as the FDA, EMA or national authorities, and ensure that products comply with local and international regulations.
He works closely with other departments, such as Quality Assurance, Research and Development (R&D), Production and Quality Control, to ensure that the product is not only effective and safe, but also complies with regulatory standards. It is also responsible for the continuous monitoring of regulatory compliance throughout the product lifecycle, managing post-marketing updates and preparing the company for regulatory audits and inspections.
- As a Regulatory Affairsspecialist , what do you consider to be the main objective of your department within Asacpharma?
The main objective of any Regulatory Affairsdepartment is to comply with the regulatory requirements applicable to all the company’s products, so that they comply with the standards of each country and can be marketed appropriately.
It should not be forgotten that these regulatory requirements are established by the regulatory agencies to safeguard the safety and efficacy of the products, always for the benefit of the patients who will receive them. Consequently, another objective of our department is to check internally that Asacpharma products are produced and marketed in accordance with these regulatory requirements, in direct contact with other departments such as Quality Assurance or Quality Control. This includes changes that may occur in the product, such as changes in the manufacturing process, in the methods of analysis or suppliers, which we must evaluate and accept internally and notify to the regulatory agencies.
On the other hand, it is very important that the creation and development of a new product is done bearing in mind that it must comply with the applicable regulatory requirements, otherwise a lot of time and money would be wasted in developing a new product that will not be marketed. Therefore, at Asacpharma, the Regulatory Affairs department is involved in the creation of new products from their conception, supporting the R&D department.
We are also responsible for many other tasks, such as keeping the information on medicines up to date (labelling, package leaflet and technical data sheet), which is essential for patients to be able to use our products responsibly.
- How do you handle the regulatory differences between the different countries where the company operates?
This is a complex issue, as there can be very significant differences in the regulatory requirements in each territory. Before we start operating in a new country, our department studies the requirements applicable to our product in that country, to check if the product can comply with their national standards.
In many cases, we are assisted by a local distributor who has a much better understanding of the product requirements in that territory. Therefore, it is essential to have the best possible partnersto help us in this task, which we achieve thanks to the efforts of our Export department, with whom we also collaborate on a regular basis.
Most of the time, it is necessary to adapt the product to the specific requirements of a territory, such as adapting the labelling, before being marketed there; this is what is known in project management as tailoring. Once we have studied the regulatory requirements of a country, we collaborate with Technical Management and the departments that may be affected, such as Quality Assurance and Quality Control, to make the necessary adaptations to the product before it is marketed in that new country.
- During the approval process for a new medicine or medical device, what are the biggest challenges you face during the process?
Each of the product types you name follows a different regulatory process, so the challenges are different in each case.
In the registration of medicinal products, perhaps the biggest difficulty is the extensive and detailed regulations, which entail reviewing and complying with a large number of different requirements. In addition, these regulations are constantly being updated, so we are constantly working to keep up to date with the latest changes and to remain compliant.
In the field of medical devices, the new MDR 2017/745 and IVDR 2017/746 regulations have considerably increased the regulatory requirements, bringing them closer to those of a medicinal product. The biggest difficulty here is the application of the same regulation to a very wide range of very different medical devices, ranging from a hip prosthesis or an MRI machine to a topical cream, which makes the regulation more complex.
- To ensure regulatory compliance, how do you interact with other departments, such as Research and Development (R&D) or Production?
As I have already explained, our department collaborates with almost all other departments in the company, as the regulatory requirements cover the entire product, from product development to manufacturing, control, labelling and marketing.
Consequently, we regularly collaborate with the R&D departments in the development of new products; Technical Management, Production, Quality Assurance and Quality Control regarding changes related to manufacturing and control that occur throughout the product life cycle; Marketing and Sales regarding labelling or the maintenance or deregistration of products marketed by the company; or Export in the marketing in new territories.
- In the field of medical devices, what are the main regulatory requirements to be met before they are launched on the market?
In Europe, the regulation of medical devices is very complex, as it has to cover many different types of devices. Therefore, MDR 2017/745 contains classification rules which, when applied to the products in question, basically divide them into four classes from least to most dangerous to the patient: Class I, IIa, IIb and III. The higher the classification of a medical device, the higher the regulatory requirements it must meet in order to demonstrate its safety and efficacy and, consequently, to be marketed.
Except in the case of class I products, all other medical devices are evaluated by regulatory bodies, called Notified Bodies, which are responsible for authorising or rejecting their marketing on the basis of scientific criteria. These Notified Bodies study the quality of the products and the non-clinical (animal studies) and clinical (human studies) data submitted by the manufacturing companies, and if this information complies with the requirements demanded by the MDR 2017/745 regulation, they grant a CE Certificate to the product, obtaining what is known as CE Marking, which allows the medical device to be marketed in the European Union. This CE Certificate must be renewed periodically, for which the Notified Bodies carry out annual audits of all manufacturers.
- How do regulations for medical devices differ from those for pharmaceuticals?
As I said before, the European Medical Devices Regulation MDR 2017/745 has considerably increased the regulatory requirements compared to the previous regulation, bringing it closer in detail to the medicines regulation.
In general, they are separate regulations and hardly comparable, as they have been developed independently and from very different points of view. For example, the regulatory regulation of medicinal products is based on a regulation on the manufacture of medicinal products (GMP standards), while the regulation of medical devices includes both regulatory aspects and those related to their manufacture, including audits of manufacturers.
What is similar is the emphasis on safety and efficacy for patients, which are at the heart of all health regulation.
- How do you keep up to date with changes in medical device regulations, both nationally and internationally?
The AEMPS, as the national authority responsible for the surveillance of medical devices marketed in Spain, and the European Commission, as the European authority responsible for the application of the MDR 2017/745 standard, publish on their website all regulatory developments, which we review periodically. In addition, the audits that manufacturers receive both from the AEMPS, in relation to the national manufacturer’s licence that is essential in Spain, and from the Notified Bodies are also an opportunity to find out about the latest regulatory developments, even before they come into force.
- What projects are you currently working on in the Regulatory Affairs department of Asacpharma (Centrum/API)?
For Especialidades Farmacéuticas Centrum , we are currently working on obtaining new drug authorisations for our musculoskeletal line, as well as obtaining authorisation for our medical device Hyplus, with CE marking in accordance with MDR 2017/745, for other territories outside the European Union.
For our laboratory API, manufacturer of biological allergy medicines, we are immersed in the adaptation to the recently entered into force Order SND-778-2023, which regulates allergen-based medicines in Spain. And, of course, we continue to work with the Export Department to register our allergy products in new territories.
- What are the department’s short- and long-term prospects?
At the moment, especially with the new regulation of allergen-based medicines, a period of intensive work is opening up, both in the short and long term, as this regulation is expected to last at least until 2030. This project will be the focus of most of our department’s efforts in the coming years.
