Regulatory strategy for medicinal products

Regulatory issues are becoming increasingly complex. It is difficult to keep an overview in the jungle of legal regulations and specific requirements on a product’s path to being market-ready, not to mention the necessary steps in the revision of a dossier for new procedures and/or complex variations. It is therefore advisable to already have as precise a plan as possible for the procedure and its objectives – i.e. a regulatory strategy – right at the launch of a new development, revision or idea.

The goal is the path

It is imperative that an adequate regulatory strategy predefine the objectives to be achieved. The procedure for which this is being done is irrelevant. Whether it is the implementation of a variation (such as extension of an indication, new manufacturing method, new name, etc.), a new authorisation, a new claim, or a Rx-OTC switch project. A regulatory strategy sets this project objective as a guideline and outlines the ideal regulatory path to achieving it. For example, a mutual recognition procedure with an old authorisation may look like the fastest option, but this might not be the most sensible approach.

The regulatory strategy deals not only with the type of submission but also incorporates necessary documents, time and costs into its assessment. Ideally, the corresponding advantages and disadvantages of the procedure in question are discussed and evaluated.

A strategy will often include the recommendation to involve the responsible authority (in Germany, these include the Federal Institute for Medicinal Products and Medical Devices BfArM or the Paul-Ehrlich Institute) as regards particularly controversial points in order to clarify the authority’s opinion and adapt the regulatory path where necessary. A regulatory strategy should therefore always be flexible enough to adapt to new regulatory requirements.

Depending on the objective, be it the fastest, cheapest or safest option, we then sit down with our client and develop the ideal path for the project.

Seizing regulatory opportunities

It is absolutely essential to have a fundamental knowledge of the regulatory environment of the product in question in order to have any prospect of a successful project. In-depth knowledge is an advantage when aiming to avoid obstacles or uncertainties early on as well as for a more efficient project design. Experienced regulatory affairs specialists will be able to find regulatory niches in many cases and so contribute to the uniqueness of a product, for example. Again, the most direct path is not always the best one. Using another path might enable the development of completely new opportunities and possibilities for the project.

Contrary to what many companies assume, the regulatory strategy not only serves to ensure conformity with existing requirements, time lines and deadlines, but can also be implemented proactively. Early integration of regulatory affairs is therefore important and necessary to enable a smooth project development

Diapharm has already developed suitable regulatory strategies for a variety of companies. Our strength lies in our ability to think outside the box, find creative solutions and, of course, implement them.

Dr. Christoph Buss
Associate Director Pharmacovigilance & Scientific Information
Mag. pharm. Dr. Siegrun Gerlach
Director Diapharm Austria


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