The MHRA has published detailed guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs), under the following headings:
- Legal background and scope
- Submission of information
- Initial appraisal
- Studies remaining within EU framework
- Processing and assessment of outcome of EU Article 45 work sharing procedures
- Contact
UK MAH holders who sponsor a study which involves use in the paediatric population in respect of the medicinal product to which that authorisation relates must submit to the MHRA, results of the study within the period of six months beginning with the day on which the trial ends. This applies irrespective of whether or not:
- the studies are conducted in accordance with an agreed paediatric investigation plan (PIP); or
- the MAH intends to apply for a marketing authorisation for a paediatric indication in relation to the product.
These provisions replace Article 46 of Regulation (EC) No 1901/2006 (the ‘Paediatric Regulation’).MHRA will also consider the outcome of CMDh paediatric work-sharing procedures (PdWS) reviewed under Article 45 of Regulation (EC) No 1901/2006 (as amended). If required, MHRA will request updates to the product information (PI) for UK Marketing Authorisations.You can read the guidance here.
Source: MHRA