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2022 Rome Action Plan on Paediatric HIV & TB



EMA and USFDA commit to:

42 Work with other regulatory authorities within the International Council for Harmonisations of Technical Requirements for Pharmaceuticals for Human Use (ICH) 11 to advance development of supportive regulatory guidance in alignment with the Call To Action principles.


43. Encourage sponsors to consider innovative approaches (i.e., combination DART study designs, as outlined in ICH S5(R3), Section VII) to help expedite DART data collection.


44. Continue to consider the benefit and risks of new molecular entities under development to determine, on a case-by-case basis, and provided that the nonclinical safety data are supportive, whether participants who become pregnant during a clinical trial can remain in the clinical trial and continue to receive the investigational drug. The agencies will continue to proactively engage with sponsors throughout the drug development period to discuss and consider the benefit/risks of an investigational drug when used in women who become pregnant during clinical trials. In addition, to facilitate approaches to increase enrolment of certain underrepresented populations, The FDA has published a guidance, Enhancing the Diversity of Clinical Trial Populations –Eligibility Criteria, Enrolment Practices, and Trial Designs, accessible at


45. Continue to encourage sponsors to collect pharmacokinetic (PK) data in pregnant women to characterize effect of pregnancy on drug exposures (e.g., AUC, Ctrough). PK data maybe collected in pre-approval clinical trials when appropriate for pregnant participants to remain in the trial, or through post-approval clinical studies in pregnant women.


46. Continue to work with sponsors to update USPI/EMA PI as additional data become available.


47. To the extent feasible, continue to collaborate with other regulatory agencies on aspects of drug development, including trial designs, endpoints, safety monitoring plans, and patient eligibility criteria (such as pregnant status) for inclusion in clinical trials.


EMA commits to:


48. Update the CHMP guideline EMEA/CHMP/203927/2005 Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling.


49. Engage in dialogue with medicine developers regarding timing of non-clinical developmental and reproductive toxicity studies to identify opportunities and challenges for completing them earlier.


50. Promote and support use of standardized and harmonized methods for signal detection and post-authorisation safety studies of medicines in pregnancy and lactation.





All partners commit to: 


163. Address inequities by tackling the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment. 

164. Increase literacy about CD4 testing and viral load and promote a client-centred approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment, including at the point-of-care. 

165. Review and assess emerging co-infections for immunocompromised infants and children, including those with advanced HIV disease, such as severe bacterial infections, fungal infections, and others for country consideration and implementation.

166. Engage affected communities for input and guidance on investment and programmatic priorities, provide support to in-country civil society organizations to engage in advocacy and demand creation for new tools, and ensure data is publicly available to support communities and civil society to monitor progress regarding uptake and implementation of essential diagnostic tools.




EMA commits to:

268. Continue to participate in the Paediatric ARV Drug Optimization (PADO) and Paediatric ARV Working Group (PAWG) meetings and take into consideration the list of priority products in the evaluation of Paediatric Investigation Plans for related medicines.


269. Explore stepwise approach in PIP in agreement of paediatric investigation plans for treatment of HIV to align them to evolving needs of different paediatric age-subgroups.




European Medicines Agency commits to: 

408. Participate in PADO TB and continue the review of Paediatric Investigation Plans (PIPs) specifically taking into account the following points, always bearing in mind that PIPs are evaluated on a scientific case-by-case basis: 

I. Paediatric formulation development must be considered in an integrated way right from the beginning of the planning process together with the whole paediatric drug development after completion of phase 1 studies in adults, taking into account dose finding and clinical studies. 

II. Adolescents should be included in adult trials or adolescent trials should be conducted in parallel with adult trials unless scientifically justified. 

III. Studies of medicines across the paediatric spectrum of ages/weights should be conducted in parallel rather than in a serial age-staggered approach, taking into account for example the pharmacological characteristics of the particular medicinal product, e.g. specific safety or drug disposition factors which may warrant a different approach. 

IV. PIPs for new TB medicines should consider systematic inclusion of children with HIV and other common co-infections found in children, taking into account safety or drug-drug interaction issues. 


409. Provide guidance about when clinical trials for efficacy have to be done in children and adolescents and when extrapolation of efficacy based on PK is sufficient. 


410. For planned regulatory submissions to provide guidance on pathways for paediatric drug development programmes without reference products and/or TB indication in adults.  


411. Continue to work with other non-EU regulatory authorities and WHO to foster alignment on development programmes for prevention and treatment of TB in children and adolescents.


412. Identify specific mechanisms as defined by the legal framework to facilitate access to WHO Prequalified paediatric TB formulations in their countries/regions through specific mechanisms as defined by the legal framework. 


413. Continue to offer the opportunity to target countries to participate as observers in the EMA evaluation. 



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