Interpretation | Analysis of Pediatric Drug Varieties and Policy Inventory: EU

Part 1: EU legislation and supervision of children's medication

In 1997, the European Commission discussed the issue of children's medication in an expert round table organized by EMA.

In 1998, the European Union participated in the discussion of the ICH clinical guidelines for medicines for children.

In 2002, the European Commission negotiated and proposed a proposal for better medicines for children (Better Medicines for Children: proposed Regulatory Actions on Paediatric Medicinal Products).

In December 2006, the European Union passed a proposal for the Regulations on Pediatric Medicines, which came into effect on January 26, 2007.

According to the Paediatric Regulation (Paediatric Regulation), starting from July 26, 2008, all new drugs launched by European pharmaceutical companies must pass children's clinical trials, and describe the product's children's clinical trials in accordance with the requirements of the Pediatric Investigation Plan (PIP) , Provide data information.

On the other hand, according to Article 26 of the Paediatric Regulation, EMA provides free scientific advice (SA) or agreement assistance (PA) for any problems related to the pediatric research and development of drugs.

Table 1: Scientific advice and agreement assistance carried out by EMA, SAWP and CHMP from 2009 to 2018, including follow-up actions

Part 2: PUMA (Pediatric Use Marketing Authorization)

The marketing authorization of medicines in the EU is mainly through three ways: centralized review procedures, mutual recognition procedures and member states procedures.

Table 2: Drugs approved by EU PUMA

The European Union has been working hard to strengthen the management and policy support of children’s medication.

01-Determine the need for pediatric medication

02-Strengthen the cooperation of decision makers

03-Ensure the timely completion of the Pediatric Investigation Plan (PIP)

04-Improve the handling of PIP applications

05-Improve the handling of PIP applications

To sum up, the EU has established a relatively complete system for pediatric drugs in terms of legislation, technical guidelines, management procedures, and implementation paths; these years of experience in implementing regulations are important to China’s drug administration, which is currently advancing the establishment of a pediatric drug regulatory system.

Reference materials:

1- EMA official website

2- The 10th Anniversary Report of the EU "Pediatric Drug Regulations": Achievements and Challenge

3-Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this regulation

4- European Medicines Agency and European Commission (DG Health and Food Safety) action plan on paediatrics