Table 2.

The comparison of legislation in the EU, USA and China on drug research and development

	EU	USA	China
Legislation	Paediatric Regulation (EC) No 1901/2006	Best Pharmaceuticals for Children Act (BPCA); Paediatric Research Equality Act (PREA)	Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (Draft for Comments)
Instrument	PIP	BPCA: WR; PREA: PSP	Investigation plan
Rewards and incentives	1*: 6-month SPC extension 2†: 2 additional years of market exclusivity 3‡:10 years of data protection	6-month exclusivity	Up to 12-month market exclusivity

*Unauthorised medicinal products and authorised medicinal products covered by an SPC or eligible for an SPC.

†Orphan-designated medicinal products.

‡Paediatric-use marketing authorisation.

EU, European Union; PIP, paediatric investigation plan; PSP, paediatric study plan; SPC, supplementary protection certificate; WR, written request.