Find your way through regulations to licence your product

From drug development to marketing authorization, the regulatory affairs team is a key player in shaping the product registration strategy, to identify risks well in advance to overcome obstacles on the path to product success.

Hooray ! Clinical studies on a drug from your pipeline have shown a positive benefit/risk ratio, patient needs are met and market expectation have been analysed by your marketing team, the registration of your product is your next step. But how to obtain the holy grail that is the Marketing Authorisation?

A regulatory strategy

Your marketing team has identified countries of interest, it then needs to be translated into a regulatory strategy. It will describe the regulatory path to obtain licences in the selected countries, the type of registration procedure (centralised, decentralised, mutual recognition or national procedure), how the application will be positioned (full application, bibliographic application, a generic product), in which EU countries you are planning to submit the application and maybe outside EU for a broader and later business development. Defining markets in advance can have a significant impact for example on the budget and timings of stability studies to be conducted. Also, a detailed knowledge of the regulations is required to develop your product from the start in line with the highest quality standards.

Interacting with authorities

Meeting the authorities may be required to confirm your development strategy for the registration of your product. It is an opportunity to present to authorities a summary of clinical data obtained during the development of a product, to evaluate a Pediatric Investigational Plan, to discuss statistical analysis of results or quality maters for chemical or biotechnological product during Scientific Advice Meetings. Similarly, regulatory questions can be debated with authorities during a Regulatory Advice Meeting, with regards to for example a specific aspect of a procedure, the choice of product name or the label content.

Making the application

eCTD, eAF, CESP….?

Here comes the time to build the regulatory dossier to then apply for a Marketing Authorisation (MA). The dossier is built according to the Common Technical Dossier requirement (CTD), and covers the Quality, Nonclinical and Clinical detailed information (Modules 3 to 5), summaries of which are provided in Module 2, whilst Module 1 contains the regional administrative information. The aim of the dossier is to demonstrate the quality, safety and efficacy of the product, and compliance with the latest guidelines and regulations.

Specific attention must be given to the Summary of Product Characteristics (SmPC), as it describes the properties and the officially approved conditions of use of your medicine. Summaries of Product Characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively.

Submission of the dossier to authorities is done electronically according to specific standards, using electronic Application Form (eAF), through a Common European Submission Platform (CESP). The specific format used for the publishing of the regulatory dossier is suitable for the exchange of information with authorities during the MA application procedure, but also for any later Life Cycle Management, via the submission of variation and renewal procedure applications.

Once the application has been submitted and successfully validated by authorities, starts the assessment of the dossier by the competent authorities. During the procedure, assessors may require clarification on the submitted information for example, on Active Substances documentation and control, Finished Product manufacture, analytical methods, or question the analysis of clinical studies results. The responses provided need to demonstrate the necessary process control and knowledge of the product. Authorities may request to provide additional data via a commitment to be fulfilled within an agreed timing after the issuance of the Marketing Authorisation.

Entering the market

Congratulation, you made it! A Marketing Authorisation has been granted by authorities. The last hurdle before you sell the product is to access markets and to satisfy to national regulations. This can include last discussion on the labelling texts, the selling price of your product and if it is eligible for reimbursement, and other specific legal obligations. After completion of these last steps, and once promotional materials are available, you will finally be able to promote and successfully launch your product on the market to improve patients’ conditions.

What’s next ?

The successful life of your product starts now, thanks to innovative promotion and advertising campaigns.

To remember: regulatory files must be regularly updated, to reflect quality improvement implemented and the increasing knowledge of the product through life cycle management. But this is a whole different story ….