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1996 Comprehensive Nuclear Test Ban Treaty (not yet in force)—snapshot

1996 Comprehensive Nuclear Test Ban Treaty (not yet in force)—snapshot Snapshot of the Comprehensive Nuclear Test Ban Treaty Title Comprehensive Nuclear Test Ban Treat (CTBT) Parties 185 signed. 170 ratified Signatories Adopted 10 September 1996 Opened for signature 24 September 1996 Not in force The treaty requires ratification by all Annex 2 countries Status of ratification Subject The ban of all nuclear explosions Status of the Treaty The treaty cannot come into force until it is ratified by the Annex 2 States listed below. These are States that took part in the negotiation of the CTBT from 1994–96 and that had nuclear power or research reactors at the time. Annex 2 States Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Democratic People's Republic of Korea, Egypt, Finland, France, Germany, Hungary, India, Indonesia, Iran (Islamic Republic of), Israel, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Republic of Korea, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom...

EU regulatory data protection

EU regulatory data protection Directive 2001/83/EC (the Pharmaceutical Code) establishes a period of ‘data exclusivity’ from the initial authorisation of innovative medicinal products during which the pre-clinical and clinical trial data generated and used to support the authorisation of an innovative medicinal product cannot be referred to by an applicant for a marketing authorisation (MA) for a generic product. Data exclusivity therefore serves to offer a guarantee to innovative companies that scientific data generated for the MA of the innovative medicinal product is protected and will not be used to assess applications from manufacturers of generic or biosimilar medicinal products until after expiry of the data exclusivity which the innovative medicinal product enjoys. This period of data exclusivity is also known as regulatory data protection (RDP). This Practice Note provides an overview of the applicable EU provisions governing RDP of MAs for innovative medicinal products and explores how it impacts on the entry of generic and biosimilar medicinal products into the market. Introduction to the concept of regulatory data protection...