• the proposal for a European Parliament and Council directive relating to the implementation of good clinical practice (COM(97) 369 final, 3.9.1997) requiring the preparation of further guidelines; • the proposal for a European Parliament and Council regulation on orphan medicinal products, for which designation-related activities, protocol assistance, and specific guidelines and dedicated database can be anticipated; • the integration of the EMEA in the Joint Action, adopted by the Council, on new synthetic drugs (OJ L 167, 25.6.1997, p.