A Product License must be obtained prior to the commercial supply of a medicinal product. This can be in the form of a Product Licence (PL) in the USA, or a Marketing Authorisation (MA) in the UK. A Product Licence is a collation of the product’s technical, quality, manufacturing, and testing data along with preclinical and clinical information. The applicant is also responsible for demonstrating the compliance to cGMP as part of the product licencing process.
Licence applications are required to be made in Common Technical Documents (CTD) format for submission to Regulatory Agencies. The data and format requirements are outlined in the following:
European Medicines Agency – Scientific Guidelines
The main MAA registration process steps are:-
1. If relevant and appropriate, Regulatory Agency meeting(s) to discuss and agree the submission framework and strategy. A new filing, Orphan Registration, Abridged Application, etc.
2. Collation of all relevant information and data for the preparation of the MAA submission file
3. Preparation of the submission file in eCTD format
4. Internal and external expert review of the eCTD submission-ready components to ensure clarity, consistency and overall quality and attention to detail
5. Submission to the appropriate authority
a) Mutual Recognition Procedure, MRP (EMA)
b) Centralised Procedure, CP (EMA)
c) Decentralised Procedure, DCP (EMA)
d) NDA Application (FDA)
e) National Applications (MHRA, HPRA, BfArM, etc.)
6. Preparation for and participation in the Pre-Approval Inspection (PAI) and cGMP audit(s)
7. Preparation and responses to Agency questions and requests for information (RFI)
8. Receipt of MA Approval
9. Completion of post-approval commitments
The Regulatory Authorities review the application file and following responses to questions, and the outcome of the site or plant inspection (PAI), will decide whether a Product Licence should be granted. For biopharmaceutical MAA filings there are a number of additional considerations that must be taken into account, such as facility design, full method and process validation; when the registration file is in preparation.
Following approval of the product licence, lifecycle maintenance is required to ensure that Product Conformance is maintained. A robust Change Control Process is critical in ensuring both compliance and conformance. As the regulatory framework has undergone significant change in recent years, companies need to be aware of changing requirements, including mandatory rulings involving the conversion of original Notice to Applicant (NtA) filings to Common Technical Document (CTD) format, and more recently eCTD requirements.
How Woodley BioReg can help with Product Licensing
Woodley BioReg has expert level knowledge and understanding of all aspects of the EU and US registration pathways, and provides comprehensive advice on the development of regulatory and submission strategies, as well as managing all regulatory agency interactions.
Woodley BioReg helps and advises pharmaceutical, biopharmaceutical and healthcare companies by providing support in specific therapeutic areas, or with framework knowledge to support any in-house resource deficiencies. WBR also support smaller, specialist, or non-EU / overseas manufacturers that do not have either in-house Regulatory Affairs departments or a presence in Europe, with their regulatory and registration objectives.
For more information, help and advice on Product Licensing, please contact us.