Pharma Knowhow

The Role and Responsibility of the Regulatory Affairs Department


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Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science companies ensure that their companies comply with all of the regulations and laws concerning their business.


The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.


Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products.


Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates, all of which necessitate the involvement of the Regulatory Affairs’ department. Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role, for example, by considering the best processes to follow and enabling structured interaction with regulatory authorities. Regulatory Affairs is driven by good science and accordingly nothing remains static.


Regulatory affairs professionals are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan. Development targets and key claims have to be reviewed and adapted to regulatory guidelines and regulations. Consultations with the appropriate regulatory agencies, for example Scientific Advice procedures in the European Union (EU) or pre-IND meetings with the FDA, are milestones in product development. Regulatory professionals ensure that the information and data to be conveyed and discussed with the regulatory bodies are presented in the right way and form. They develop the regulatory strategy, arrange agency meetings, prepare and compile the questions and briefing documents; they attend the meetings and manage all communication with the agencies. Since the regulatory environment is constantly changing the regulatory team provides advice on necessary adaptations to development plans and target product profiles.


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At the late stage of product development regulatory professionals are responsible for the submission of the registration dossier, e.g. Marketing Authorisation Applications (MAA) in the EU or New Drug Applications (NDA) in the US. It is their responsibility to provide the strategic regulatory framework for the submission, to advise on procedures and formats, to collect, evaluate and compile the scientific data and information on the product. They manage the communication and negotiations with the authorities. They are accountable for maintenance of marketing authorizations and are involved in the life-cycle management of a product.

Due to constantly increasing regulatory obligations and new requirements as well as the globalization of the pharmaceutical market, the demands and responsibilities of regulatory departments is becoming more and more complex.


New regulatory requirements: The introduction of the new paediatric legislation in the EU – Regulation (EC) No 1901/2006 as amended (the ‘Paediatric Regulation’) – with the obligation to submit Paediatric Investigation Plans (PIP) or requests for waivers, has added new challenges to the work of regulatory professionals. Since July 2008 new applications for marketing authorization are only validated if they include either the results of studies (conducted in compliance with PIP) or an EMEA decision on a waiver or on a deferred PIP. The paediatric strategy must therefore be considered early on and built into the overall development plan to avoid any delays in view of market access of the product.


New product types: The pharmaceutical industry is increasingly relying on biotechnology for future growth. There is also interest in obtaining access to specialist-driven indications, or narrow patient populations, in niche technologies and advanced therapy medicinal products (ATMP).


On 30 December 2008, new legislation on advanced therapy medicinal products came into force in the European Union. The regulatory framework for ATMPs is established by Regulation (EC) No 1394/2007. As a result of these developments regulatory departments are in need of expertise in these new product types and in new areas of science.


Acquisition / In-licensing: The trend towards increasing acquisition and in-licensing activities of the pharmaceutical industry also presents regulatory departments with new challenges. The acquisition of complete product groups raises questions on transfer of the marketing authorization holder, integration of the acquired dossiers into the regulatory processes and document management systems, on adaptation to production changes, on dossier updates. The consequences are complex and require strategic programme management as well as appropriate resources.


Acceleration of time to market: Today pharmaceutical companies are in a race to place new products on the market. The increasing costs of development programmes are a major challenge for the pharmaceutical industry. Time to market is a critical index for pharmaceutical business and the key to return on investment. Acceleration strategies put tremendous pressure on regulatory departments since delays in approvals mean a massive loss in revenue generation.


Emerging markets: Although the US and Europe are still the major markets, the emerging markets of Brazil, Russia, India, China, Mexico, South Korea, and Turkey are rapidly growing. The need to understand and adapt to the new complex regulatory requirements in these emerging markets is placing new demands on regulatory departments. Due to the still considerable differences in documentation requirements, regulatory procedures, ways of communication with the authorities, CMC regulations, importation regulations, etc., local regulatory knowledge is the key to success in any new market.


To meet all these challenges pharmaceutical companies need on the one hand additional resources to cope with peak workload. On the other hand they need expert knowledge and local experience to face the demands of new regulatory environments and requirements. The companies can either ramp up their regulatory departments or complement their internal resources by outsourcing of specific tasks.

There is an increasing trend towards outsourcing, which leads to cost-effective and lean processes. Having additional resources at hand for a certain period of time and sourcing specific expertise and local knowledge when needed keeps the regulatory departments agile and flexible. What is important to such an outsourcing strategy is the selection of the right partner at the right time. Selection criteria for outsourcing partners very much depend on the nature of the tasks to be transferred but also on the structure and organization of the pharmaceutical company concerned.


There is a great variety of regulatory consulting companies: Large firms acting globally with local presence in different countries, small firms specializing in one or the other area of regulatory affairs or specific regions. Identifying the right partner at the right time is vital to successful outsourcing. At pharmaceutical companies can place requests for regulatory affairs specialists using the category “Regulatory services” or “Consulting service”. These requests describe very specifically the sought experience, staff, technology, operational systems, and methodologies. Requests can be placed immediately. In addition, by using the same categories companies can actively search the platform for specific services offered by service providers. Distinct regulatory service offers are constantly placed in the categories “Regulatory services” or “Consulting service” from service providers in EU and USA. There are offers for example for the regulatory strategy, for the preparation of the Common Technical Document (CTD) used for marketing authorisation applications in the EU and New Drug Applications in the U.S., preparation of dossiers for variation in the EU and supplements in the U.S., orphan drug applications, PIP submissions, PSURs and other items.


Pharmaceutical industry and Health Authorities regulating medicinal products continuously need to recruit staff in Regulatory Affairs departments. With the increasing role of biopharmaceuticals, they increasingly search for professionals with the distinctive knowledge required to handle biopharmaceuticals adequately. Most of the Regulatory Affairs professionals have a degree in either pharmacy or medicine or another relevant life science or health subject. It is always possible in the professional life to start a career in Regulatory Affairs and it can be based on varying background. The European Centre of Regulatory Affairs Freiburg, EUCRAF with its Postgraduate Master Course offers for the first time in Europe an education with a special focus on biopharmaceutical-related Regulatory Affairs.

TOPRA as an organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector offers a special MSc in this field with lectures taking place in UK.


A post-graduate master course in regulatory affairs is also offered by DGRA, the German Society for Regulatory Affairs with lectures taking place in Bonn, Germany.


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