Regulatory affairs
Regulatory strategy
Unlike other regions, in the EU a number of options are available to obtain a marketing authorisation. Centralised at the European Medicines Agency in London or decentralised with the individual competent authorities of the member states, each marketing authorisation application procedure has its pros and cons. And even more, duplicate and parallel import licenses also provide for a not so obvious route to marketing authorisation.
Marketing authorisation applications
As mentioned, various marketing authorisation procedures can be used in Europe. The actual submission of the dossiers to regulatory authorities, subsequent monitoring of the procedure, responding to regulatory queries and the formal ending of the application procedure is a complicated and time consuming activity. DADA has gained extensive experience in these activities and is able to manage complete CP/DCP/MRP projects involving all European countries on your behalf. We are not limited to the European Union only, but also active in emerging markets, such as Russia or Ukraine.
Marketing authorisation dossiers and maintenance
DADA has produced over 500 complete state-of-the-art marketing authorisation files for medicinal products that have been successfully registered throughout Europe. For many of these marketing authorisations DADA also performs dossier maintenance throughout the life-cycle, resulting in an on-going series of variation and renewal applications that are submitted to the competent authorities.
Naturally our dossiers conform to the current EU or US requirements of the electronic common technical dossier eCTD, and we can convert your dossier to this format as well. Dossiers can also be provided in the locally accepted non-eCTD electronic submission formats, if required.
Local representative of the Marketing Authorisation Holder
A marketing authorisation may only be granted to an applicant established in the European Community (Art 8 2001/83/EC). Furthermore, some member states require a local representative be appointed and included in the contact details of the Patient Leaflet, as is the case in the Netherlands (Article 71 Dutch Medicines Law). DADA has the required legal entities and organisation in-house to act as your European Community establishment and/or as local representative in the Netherlands, including liaison with health care professionals or the public in the local language, handling of product questions or complaints, and more.
Expert reports, overviews and quality overall summaries
At the moment DADA has produced more than 1300 state-of-the-art expert reports, (non)clinical overviews and quality overall summaries that have been successfully included in marketing authorisation applications approved throughout Europe. DADA guarantees compliance of its expert reports, (non)clinical overviews and quality overall summaries with all current regulatory requirements.
Program and Project management
DADA can offer complete program and project management solutions using its extensive knowledge and experience in product development and the registration of generic and generic ‘plus’ human and veterinary medicinal products,. This includes large projects as described under product development as well as sub-projects, such as the management of complete centralised procedures (CPs), decentralised procedures (DCPs), mutual recognition procedures (MRPs), translational work, management of CRO selection, preparation of documents for variation applications etc.
Scientific Advice
Depending on the developmental or regulatory problem statements at hand, it can be highly beneficial to actively seek scientific or regulatory advice from competent authorities. Established Guidelines as well as scientific knowledge may change over time and insight in current agency thinking of actual or future developments may avoid inappropriate decisions. DADA will help you obtain the best possible agency advice by selecting the most appropriate, centralised or national European agency, assisting in preparation and submission of the advice request package and visiting the agency for oral explanations; or managing the entire advice procedure on your behalf.
EU language translations
Module 1.3 of the CTD marketing authorisation file must be submitted to the competent authorities in the language of the European member state concerned. Although DADA is not a translation agency itself, we partner with a top quality translation company experienced in pharmaceutical/medical translations. Of course this company translates other modules as well. Thus DADA can provide optimal support to its clients.
PIL user testing
In accordance with current legislation, Patient Information Leaflet readability testing is a mandatory part of a human medicinal product marketing authorisation. Therefore DADA has developed a state-of-the-art method for user testing.
WHO Certificate of a Pharmaceutical Product / Free sales certificates
DADA can apply for CPPs / free sales certificates of products registered in the Netherlands.
Reimbursement applications
After granting the marketing authorization, the product concerned must be included in the national reimbursement system of each member state concerned. In the Netherlands this means that a reimbursement file must be submitted to the authorities. DADA can support you in compiling these reimbursement files.
Appeals and hearings
DADA also supports its clients in appeals and hearings. Due to extensive pharmaceutical knowledge and knowledge of EU regulatory affairs, DADA has been able to support its clients in court cases, appeals and hearings throughout Europe.
Due Diligence and In and Out Licensing support
Whenever a pharmaceutical company signs an in-licensing contract, the quality of the existing data in the form of files or dossiers should be duly evaluated. DADA is not only well able to evaluate this regulatory dossier, but we can also support you in assessing the proposed contracts concerning this transaction. And via our network we can bring an interesting project to the attention of potential in-licensors.
Organisational advice
DADA can function as a virtual private regulatory affairs department of your company. However, if you wish to establish your regulatory department on site, we can assist and advise you how to best set this up, using our in-depth knowledge of the communications flow between functions that are required.