Wednesday, 10 March 2010
Regulatory news
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Below are some of the recent key regulatory news items we have noted, including those from the regulatory agencies and authorities in Europe and around the world. A two-letter code is used at the beginning of each item to indicate the country or region, according to the ISO list. If you would like advice relating to any of these news items, please contact us.
- [UK] MHRA: Public consultation (ARM 66): Request to extended maximum treatment period and make pack size changes to Voltarol Emulgel P
This consultation seeks your views on changes to Voltarol Emulgel P.
Mon, 08 Mar 2010 - [DK] Danish Medicines Agency: Chief Medical Officer of the Danish Medicines Agency appointed new member of the EU Pharmacovigilance Working Party
Torbjörn Callréus, Chief Medical Officer of the Danish Medicines Agency’s Consumer Safety Division has been appointed co-opted expert for the European Medicines Agency#039;s Pharmacovigilance Working Party, PhVWP.
Mon, 08 Mar 2010 - [DK] Danish Medicines Agency: Amendment of executive order on euphoriant substances
On 4 March 2010 new substances were included in annex 1 of executive order no. 749 of 1 July 2008 on euphoriant substances issued by the Danish Ministry of Health and Prevention.
Mon, 08 Mar 2010 - [EU] European Medicines Agency: Adopted appendix 2 to the guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 REV. 3) on Haematological malignancies
The European Medicines Agency have published: Adopted appendix 2 to the guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 REV. 3) on Haematological malignancies
Wed, 03 Mar 2010 - [EU] European Medicines Agency: Request of confirmation of the applicability of the Agency decision on class waivers
The European Medicines Agency have published: Request of confirmation of the applicability of the Agency decision on class waivers
Wed, 03 Mar 2010 - [EU] European Medicines Agency: Draft guideline on Real time Release Testing (formerly Parametric Release) for external consultation
The European Medicines Agency have published: Draft guideline on Real time Release Testing (formerly Parametric Release) for external consultation
Wed, 03 Mar 2010 - [EU] European Medicines Agency: Concept Paper on the Revision of the Guideline on Process Validation
The European Medicines Agency have published: Concept Paper on the Revision of the Guideline on Process Validation
Wed, 03 Mar 2010 - [EU] European Medicines Agency: Concept Paper on the Revision of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation
The European Medicines Agency have published: Concept Paper on the Revision of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation
Wed, 03 Mar 2010 - [EU] European Medicines Agency: Questions and Answers on Stability Issues of Pharmaceutical Bulk Products for Use in Manufacture of the Finished Product
The European Medicines Agency have published: Questions and Answers on Stability Issues of Pharmaceutical Bulk Products for Use in Manufacture of the Finished Product
Wed, 03 Mar 2010 - [NL] EIA: Escitalopram generic suspension lifted
[Google translates] In its meeting of February 25, 2010, the Medicines Evaluation Board again decided on an objection by the company Lundbeck against entry of certain products containing escitalopram. The objection is unfounded so the earlier suspension of these drugs is eliminated.
Wed, 03 Mar 2010