News
EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
05.06.2014
The guideline addresses the requirements regarding manufacturing processes, the biosimilar comparability exercise for quality, considering the choice of reference medicinal product, analytical
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RAPS: India Issues Final Rule on Compensating Clinical Trial Deaths
05.06.2014
India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be
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RAPS: FDA Finalizes Expedited Product Guidance With Hundreds of Major, Minor Changes
05.06.2014
The US Food and Drug Administration (FDA) has finalized its long sought-after guidance document on the use of its four expedited drug approval programs, including the recently instituted
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EC: EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use
29.05.2014
Volume 2 of the publications \"The rules governing medicinal products in the European Union\" contains a list of regulatory guidelines related to procedural and regulatory requirements such as
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RAPS: Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting
29.05.2014
The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its \"Unified Agenda,\" outlining six new rules it says it intends to
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EMA: European Medicines Agency welcomes publication of the Clinical Trials Regulation
29.05.2014
The European Medicines Agency (EMA) welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (EU). This legislation will open up a new era for the
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EMA: Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products
29.05.2014
The currently approved ‘guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products’ came into operation in January 2005. Since then, new fibrin sealant
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EMA: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
22.05.2014
This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are
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GMP: WHO publishes Draft on Process Validation
22.05.2014
WHO published a proposal for a revision of appendix 7 (non-sterile process validation) as a supplementary to the Guidelines on Good Manufacturing Practices. The reason given for the revision is
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GMP: Validation - Revision of Annex 15: Industry\'s \"problems\" - Results of an ECA Industry Survey
22.05.2014
The European Compliance Academy (ECA) has carried out a survey to determine how industry assesses these possible changes and the uncertainties that exist concerning the revision draft. ...