The certification procedure for small and medium-sized enterprises is a European procedure for the assessment of quality data and, where applicable, non-clinical data for an advanced therapy medicinal product under development. The Committee for Advanced Therapies assesses the extent to which the submitted data comply with the standards of a subsequent marketing authorization application. The outcome facilitates development planning but is not a marketing authorization.
Purpose and Legal Basis
Article 18 of Regulation (EC) No 1394/2007 offers micro, small, and medium-sized enterprises the opportunity to have data for ATMPs certified. The EMA describes the purpose as the early detection of potential problems so that they can be addressed before a marketing authorization application is submitted. The subject matter includes quality data and, if available, non-clinical data, which may have been generated at any stage of development.
The CAT conducts the scientific assessment and may recommend the issuance of a certification. Regulation (EC) No 668/2009 contains more detailed rules for assessment and certification. The procedure is explicitly tailored for SMEs; therefore, the corresponding recognition as an SME by the EMA is a procedural aspect and not merely a company description.
Procedure and Content of Data Assessment
The EMA specifies a 90-day period for the assessment. Submissions are not abstract development intentions but structured documentation on the available quality status and, if applicable, the non-clinical data situation. The assessment cannot anticipate a complete quality specification, nor does it replace missing data with assumptions.
The certification attests to the degree to which the available data comply with the level required for a marketing authorization application. It can thus highlight development gaps and support subsequent investment or partnership decisions. However, subsequent changes to the product, manufacturing process, or development program may limit the validity of already certified data and require appropriate classification.
Distinction from Marketing Authorization and Scientific Advice
A certification is not a marketing authorization. It neither permits marketing nor replaces the full benefit-risk assessment of a subsequent application. The focus is on the quality and, if available, the non-clinical basis of an ATMP; clinical efficacy and safety are not definitively determined by it.
Compared to Scientific Advice, certification differs in its subject matter and outcome. Scientific Advice is prospective scientific consultation on development issues. The certification procedure, in contrast, examines existing documentation and concludes with a determination of its proximity to marketing authorization standards. Both instruments can fulfill different functions in the development program.
This instrument allows SMEs to have the maturity of their data formally assessed without having to submit a complete marketing authorization application. The decision does not simply state ‘passed’ or ‘failed’; it indicates the extent to which the submitted information meets the requirements for a marketing authorization application. This statement is only reliable for the specific data presented. It does not automatically cover new manufacturing variants or non-clinical findings obtained later. Therefore, in project management, the submission deadline, the scope of each data section, and any changes that have occurred since then should be clearly separated. This prevents a limited certification from being mistakenly interpreted as a general confirmation of the entire development program.
Certification can therefore be useful when a company needs an early external assessment of available product knowledge. It is not a guarantee that a subsequent application will be reviewed without further questions. Subsequent clinical data, new safety findings, and the complete benefit-risk assessment remain part of the marketing authorization procedure. The practical effect lies in the qualified classification of the data status achieved, not in anticipating the final regulatory outcome.
Relevance for clinical trials
For SMEs, certification can sharpen the question of which quality and non-clinical evidence must be closed before a major clinical investment. In study planning, it is particularly important that the batches actually used, analytical methods, and product changes match the submitted data status. A certificate does not relieve one of a robust IMPD strategy or the approvals for individual clinical trials.
Full-service CROs like Mediconomics support project planning for the compilation of certification-relevant quality and non-clinical documentation. They structure document lists, coordinate contributions from manufacturing and development teams, check consistency with clinical application documents, and prepare regulatory responses in such a way that data gaps and change histories are clearly documented.
Frequently Asked Questions (FAQ)
How long does the certification procedure take according to EMA?
The EMA states 90 days for the CAT’s assessment. This period concerns the certification procedure and is not to be equated with a marketing authorization timeline.
Are clinical data required for certification?
The procedure assesses quality data and, if available, non-clinical data. It is specifically designed to be used during development before a complete marketing authorization dossier.
Does a certificate replace Scientific Advice?
No. Certification assesses existing data; Scientific Advice answers pre-formulated development questions. Their respective outcomes and functions within the program are different.
Regulatory References
- Article 18 of Regulation (EC) No 1394/2007 – establishes certification for SMEs with ATMP development.
- Regulation (EC) No 668/2009 – contains rules for the assessment and certification of quality and non-clinical data.
- EMA Procedural advice on certification of quality and non-clinical data – explains submission and assessment by the CAT.