Standard paediatric investigation plans
Standard paediatric investigation plans (PIPs) are for use by applicants to help the agreement of PIPs on specific types or classes of medicines. Adhering to the principles and key binding elements contained in a standard PIP will facilitate the PIP approval process.
Standard PIPs are developed by the European Medicines Agency's Paediatric Committee (PDCO). The regulatory requirements for a PIP, as set out by the Paediatric Regulation, are unaffected by standard PIPs.
In June 2015 the PDCO and CHMP adopted the final guidance for the expected key elements and requirements for PIPs for vaccines against diphtheria, tetanus and acellular pertussis infection, after taking into consideration the public comments received:
- Final paediatric investigation plan: Expected key elements and requirements for a new DTaP containing combination vaccine seeking marketing authorisation
- Comments on paediatric investigation plan: Expected key elements and requirements for a new DTaP containing combination vaccine seeking marketing authorisation
The PDCO and Committee for Medicinal Products for Human Use (CHMP) issued the draft guidance in September 2014 with the aim of harmonising the way these vaccines are developed in order to avoid duplication of similar clinical trials and unnecessary exposure of children to clinical testing:
- Paediatric investigation plan: Expected key elements and requirements for a new DTaP containing combination vaccine seeking marketing authorisation
H1N1 pandemic-influenza vaccines
The standard PIP for pandemic-influenza vaccines was developed for use during the 2009 (H1N1) influenza pandemic. It sets out the minimum set of data that had to be obtained in the different paediatric age groups, because children were the main target of the disease:
Allergen extracts for immunotherapy
The standard PIP on allergen extract products for specific immunotherapy of allergic rhinitis and rhinoconjunctivitis was first adopted in November 2009, and revised in February 2010 and in April 2013 following discussions with main stakeholders from academia and industry:
As a result of discussions with European manufacturers of allergen products and other stakeholders, the PDCO recognised the need for another revision to the Standard Allergen PIP offering the option to add the condition prevention of asthma to the existing condition treatment of allergic rhinoconjunctivitis. It is considered that this modification will improve the recruitment of children in long-term clinical trials and will facilitate ethics committees' approval. The fourth revision of this standard PIP was adopted by the Paediatric Committee at its 11-13 February 2015 meeting. The revised sections are highlighted throughout the text.
On 24 June 2010, the Safety Working Party provided its view on aluminium hydroxide contained in allergen products:
- CHMP Safety Working Party's response to the PDCO regarding aluminium hydroxide contained in allergen products
Acute myeloid leukaemia and rhabdomyosarcoma (draft)
The standard PIPs for acute myeloud leukaemia and rhabdomyosarcoma were prepared together with academic experts from paediatric oncology networks and in concert with the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA). They propose plausible targets or mechanisms of action that could address the needs for these two types of cancer: