GMP News - Pharmaceutical Development / Clinical Trials / GCP


Transitional Regulations for the New Pharmacovigilance Package: Commission's Q&A Document provides Clarity

The new pharmacovigilance package and its regulations which are entering into force in April and respectively in July this year prompt questions - mainly regarding deadlines for renewal applications for medicinal products authorisations. The EU Commission has published a Q&A document to answer these questions and to clarify further ones (e.g. about the pharmacovigilance system master file). Read more here.



FDA: QbD becomes mandatory for Generics

To support generic manufacturers, the Office of Generic Drugs (OGD) has published a 161 page example of a fictitious modified release tablet formulation. Read more.



New QP Declaration for managing Expiry Dates of IMPs

In the recently published EMA Reflection paper on IVR/IWR systems, an additional QP Declaration is introduced for managing expiry dates.  Read on here.



MHRA announces Good Clinical Practice (GCP) Discussion Forum

The U.K. Medicines and Healthcare products Regulatory Agency MHRA has created a GCP Discussion Forum. Read more.



CHMP adopts Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses

On July, CHMP adopted the Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture as a guidance for the use of cells to isolate the viruses, the needed conditions and the passage of the viruses. More can be found here.



EU Commission publishes a New Document about Duplicate Marketing Authorisation Applications

In certain cases, it may be economically and practically interesting to possess several authorisations for one and the same medicinal product. The conditions for such an exceptional situation are explained in a document published by the EU Commission. Read more here.



Extension of the Variations Regulation to Purely National Authorisations coming: new Consultation Paper published by the EU Commission

An implementing regulation is necessary to extend the scope of the Variation Regulation (EC) No 1234/2008. In the run-up of this Regulation, the EU Commission has published a Public Consultation Paper to be commented with respect to special questions on variations procedures for purely national marketing authorisations. Read more here



EMA's Current Positions on Transfer of a Marketing Authorisation

After pharmaceutical companies have been bought over, sold or merged, questions are raised about the procedure for the transfer of existing marketing authorisations to the new legal entity and the right change management. There are clear rules which have been recently updated and published on the EMA Q&A webpage. Read more here.



EMA Reflection Paper on risk based Quality Management in Clinical Trials

The European Medicines Agency EMA has recently released a draft reflection paper on risk based quality management in clinical trials. Read more.



EMA Reflection paper on IVR/IWR systems

The intent of this draft paper is to provide guidance to the sponsors and to the IVR/IWR providers. Read more.



Report on the joint Good Clinical Practice (GCP) Inspection Pilot Programme

The report on the joint good clinical practice (GCP) inspection pilot programme details the success of information-sharing and collaboration on inspections relating to clinical trials. Read more.



EMA: New Guideline on Development of Medicines for Paediatric Use

The European Medicines Agency has recently published a draft guideline on pharmaceutical development of medicines for paediatric use. Read more.



Quality by Design for Generics - Case Studies

The Generic Pharmaceutical Association (GPhA, USA) has published two examples of development reports to show how generic manufacturers (ANDA application) can implement Quality by Design and document in front of the Agency (Office of Generic Drugs, FDA). Read more here.



EMA Report on Clinical Trials outside the EU

The European Medicines Agency (EMA) published a report from a workshop on ethics and GCP in clinical trials outside the European Union. Read more.



New Guidance on Investigational Medicinal Products (IMPs) and Non Investigational Medicinal products (NIMPs)

The EU Commission has published a revision of the Guidance on Investigational Medicinal Products (IMPs) and Non investigational Medicinal Products (NIMPs). Read more.


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