The aim of this study was to compare post-authorisation measures (PAMs) from the European Medicines Agency EMAA) with data requests in fixed-termed conditional appraisals of early benefit assessments from the German Federal Joint Committee (G-BA).
The EMA can require post-authorisation measures (PAMs) if the Agency's committees consider the generation of additional data necessary from a "public health perspective to complement the available data with additional data about the safety and, in certain cases, the efficacy of authorised medicinal products".
Post-authorisation measure.
EMA: European Medicines Agency; EPAR: European Public Assessment Report; G-BA: Federal Joint Committee PAMM: post-authorisation measure Table 1 List of products with conditional appraisalsa and/or PAMsb Product Brand name Indication Conditional appraisalsd PAMse y/n Time frame (years) Number Time frame (years) Aclidinium bromide Eklira Genuair/Bretaris Genuair COPD No - 1 n.a.a
Table 3 Categories of missing data for conditional appraisalsa and PAMs Conditional appraisals (N = 35 categories) n b PAMs (N = 54 categories) n b Category Efficacy 13 22 Safety 10 22 Effectiveness 5 2 Pharmacology 0 8 Reference to EMAc 7 – PAM post-authorisation measure a19 products with 20 conditional appraisals, 33 products with 34 EPARs bNumber of data requests for each category.
Congressional aides said it was too early to know whether an Iran sanctions package would be introduced as standalone legislation or as an amendment to a measure such as a defence authorisation bill being considered by the Senate.
Where risks are not being properly controlled, REACH provides two risk management measures: authorisation and restriction.
The SAIL databank has been developed through a pragmatic approach, using a range of methods to develop a holistic multi-level solution that combines technical processes, control measures, authorisations and accountability.
The authorisation of "all necessary measures" is broad and appears to allow the targeting of Gaddafi and others who act to put civilians "under threat of attack", words that go beyond the need to establish a connection with actual attacks.
President Barack Obama may find Congress reluctant to grant him the authorisation for the military measures he has proposed for Iraq and Syria because of fears that they will be too open-ended.
The landscape and population ERA approach also demonstrates that there is a potential to change from regulation of a pesticide in isolation, towards the consideration of pesticide management at landscape scales and provision of biodiversity benefits via inclusion and testing of mitigation measures in authorisation procedures.
