Pharmaceutical regulation is increasingly a matter of strategy and innovation03 December 2020
Conversation with Daniela Mariano, Senior CMC & RA Manager Regulatory Affairs
How important is it for the pharmaceutical industry to follow the rules? How much is it worth knowing in detail all the laws that allow a pharmaceutical product to be sold on the market? Last but not least, whose job is it to manage relations with the various national authorities and to follow the thousands of procedures in place around the world to register and have a product approved? Regulatory Affairs, one of the main players both in terms of product development and compliance, is here to answer some of these questions. Daniela Mariano, Senior CMC & RA Manager heads up IBSA’s Regulatory Affairs, based at the headquarters in Lugano. She works alongside 19 other people, all specialising in the various areas, of which, as she tells us, there are a lot. “Today, Regulatory Affairs gathers fundamental information for the development, registration and marketing of a product. It’s not only the department occupied with registration procedures, but it’s also the department that gathers all the information to put together the full registration dossier. This means that the department has to work alongside all the others in product development in order to ensure more successful outcomes.”
Could you explain this to us in a bit more detail?
“Modern Regulatory Affairs is no longer a purely administrative exercise, but rather a scientific and strategic function in that it liaises with all the other departments: R&D, Quality in Pharmacovigilance, Marketing and Supply Chain. The construction of a dialogue between the various stakeholders and Regulatory Affairs is essential to speeding up and optimising processes: this is also innovative!”
In what sense?
“A Regulatory Affairs department that is involved from the outset of a project and during drug development adds a huge amount of value, helping to minimise errors and optimise registration time. This ultimately allows the product to be launched on the market more quickly. Regulatory Affairs also guides the technical departments responsible for development towards a dialogue with the authorities in a given country. For example, an effective Regulatory Affairs department sends requests for scientific advice to the various ministers to get their feedback on the documentation required to register a drug. By understanding these texts, we can then act accordingly. In fact, there have been instances in which we’ve avoided clinical trials through advice requested by Regulatory Affairs, leading to huge savings in terms of costs and time.”
Is it always a matter of “bureaucracy’ or are there other contributions Regulatory Affairs can make to support the company?
“There are other important things Regulatory Affairs can do. The relationship with the Quality Department is a good example, because this has a huge impact on the product life cycle. Once the drug has been registered and launched on the market, the company may need to make changes to the original product, maybe due to production updates or to change packaging or technical specifications. Regulatory Affairs supports the various departments in ensuring product compliance. Where the proposed changes have an impact, Regulatory Affairs begins to work in synergy with the various teams, ensuring for example that data is compiled by the Quality Department and that the dossier is updated to submit the changes to the authorities for approval. In general, therefore, consulting and involving Regulatory Affairs in advance allows updates to be examined in full knowledge of the facts and the product to be updated in compliance with the regulations in force.”
IBSA is an increasingly international company that wants to conquer various markets. How does this propensity towards internationalisation impact the work of Regulatory Affairs?
“Unfortunately, or perhaps luckily, there is not one single global “regulator’, but we mostly have rules on a national basis. Each country’s guidelines are different and our department is responsible for guiding the company in the various markets, taking into account all the requirements in a given country. It’s therefore crucial to be able to accurately assess market potential, considering that the effort in terms of regulatory work to register and keep the product compliant is substantial. So here, too, we return to the concept of strategic Regulatory Affairs, whereby the department needs to also be involved in deciding where it is worthwhile to market a product and where it is not.”
How have you responded to this need?
“Since February 2020, IBSA’s Regulatory Affairs department has centralised its activities to headquarters. From here, we manage Regulatory Affairs projects for all product types (drugs, medical devices, food supplements and cosmetics), as well as the various Regulatory Affairs departments of IBSA affiliates around the world. This allows us to offer the company a full global picture so that management can make more informed decisions.”