Product licensure overview

Pharmaceutical products must be licensed prior to the commercial supply. This can be in the form of a Product Licence (PL) in the USA, or a Marketing Authorisation (MA) in the EU and UK.

A Product Licence Application (PLA) or Marketing Authorisation application (MAA) is a collation of a product’s technical, quality, manufacturing, and testing data along with preclinical and clinical information. The licence applicant is also responsible for demonstrating compliance to cGMP as part of the product licencing process.

European Medicines Agency – scientific guidelines

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:

The main MAA registration process steps are:

  • 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.
  • Collation of all relevant information and data for the preparation of the MAA submission file
  • Preparation of the submission file in eCTD format
  • Internal and external expert review of the eCTD submission-ready components to ensure clarity, consistency and overall quality and attention to detail
  • 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.)
  • Preparation for and participation in the Pre-Approval Inspection (PAI) and cGMP audit(s)
  • Preparation and responses to Agency questions and requests for information (RFI)
  • Receipt of MA Approval
  • Completion of post-approval commitments
  • Licence and Life Cycle Maintenance through Change Control, Variations, and post approval supplements

Regulatory consulting

Typically, following their review of licence applications and satisfactory responses to RFIs and questions and GMP inspection, regulatory authorities will decide whether a Product Licence or Marketing Authorisation should be granted.

For biopharmaceutical MAAs, there are a number of additional considerations that must be taken into account, such as facility design, full method and process validation whilst the registration file is in preparation.

Following the approval of a Product Licence, pharmaceutical products enter the next phase of their lifecycle. Formal lifecycle maintenance is required to ensure that product conformance and compliance is maintained.

A robust change control process is critical in ensuring both compliance and conformance. As the regulatory frameworks continue to undergo significant changes in recent years, manufacturers must be aware of changing requirements.

Examples changes to regulatory changes include mandatory rulings involving the conversion of original notice to applicant (NtA) filings to Common Technical Document (CTD) format, eCTD requirements, compliance to Falsified Medicines Directive (FMD), post-Brexit implications for pharmaceuticals and medical devices in the EU and GB.