News
GMP: The new EU GDP Guideline - What will happen next?
27.09.2012
In order to change the \"old\" Good Distribution Practices Guideline from 1994 the European Commission published a proposal for a new version. A large number of individuals, associations,
...
MHRA: Paracetamol overdose: new guidance on treatment with intravenous acetylcysteine
27.09.2012
New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine is now in place. This includes an updated treatment nomogram. ...
EMA: Guideline on quality of transdermal patches - Draft
20.09.2012
This guideline together with the new Guideline on Quality of Oral Modified Release Products replaces the Note for Guidance on Modified Release products: A: Oral dosage Forms B: Transdermal Dosage
...
EMA: Guideline on quality of oral modified release products - Draft
20.09.2012
This guideline together with the Guideline on Quality of Transdermal Patches replaces Note for Guidance on Modified Release products: A: Oral dosage Forms B: Transdermal Dosage Forms. Part I
...
EMA: Concept paper on the involvement of children and young people at the Paediatric Committee (PDCO)
20.09.2012
This concept paper describes the European Medicines Agency\'s plans to develop a framework of interaction describing how the views of children and young people can be consulted as part of the
...
GMP: ICH Q8, Q9, & Q10 Questions and Answers - now also in force in the USA
13.09.2012
The ICH document Q8,Q9, & Q10, Questions and Answers / Appendix Q&As from Training Sessions has also been published in the United States. ...
GMP: Finally published: new EU GMP Chapter 1 with comprehensive Changes
13.09.2012
The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called
...
GMP: Finally published: new EU GMP Chapter 7 on Outsourced Activities
13.09.2012
Chapter 7 of the EU GMP Guide \"Contract Manufacture and Analysis\" has been revised, and the Directorate-General for Health and Consumers (DG SANCO) of the European Commission recently published
...
EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes
06.09.2012
The EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any update of the annexes, except for those when the
...
GMP: FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI)
06.09.2012
The FDA announced via its Center for Devices and Radiological Health (CDRH) - which is also responsible for medical devices - the publication of requirements on harmonised designation of medical
...