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EMA: European Medicines Agency announces start of process improvement of core business procedures

18.03.2011
The programme aims to improve the efficiency of processes in order to support the Agency’s capabilities to deliver sustainable results. The programme will initially focus on processes for the ...

EMA: European Medicines Agency and U.S. Food and Drug Administration announce pilot program for parallel assessment of Quality by Design applications

16.03.2011
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are launching a three-year pilot program that will allow parallel evaluation of relevant quality data ...

EMA: Guideline on the evaluation of drugs for the treatment of gastro-oesophageal reflux disease

14.03.2011
This guideline intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment of patients with gastro-oesophageal reflux ...

EMA: Procedural advice on the evaluation of combined advanced therapy medicinal products and the consultation of notified bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007

03.03.2011
Advanced Therapy Medicinal Products (ATMPs) offer new treatment opportunities for diseases and injuries of the human body. The regulatory framework established by the new legislation on ATMPs is ...

Polish Ministry of Health: Regulation amending the Regulation on determination and payment of charges related to marketing authorisations in respect of medicinal products

02.03.2011
Regulation of the Minister of Health amending the Regulation on determination and payment of charges related to marketing authorisations in respect of medicinal products ...

EMA: Guideline on medicinal products for the treatment of insomnia

25.02.2011
This Guideline should be considered as general guidance on the development for medicinal products for acute and long-term treatment of insomnia. Its main focus is on primary insomnia, however, it ...

GMP: New EMA/HMPC Reflection Paper on Stability of Herbal Medicinal Products

24.02.2011
This reflection paper addresses the need for specific requirements for establishing the stability of herbal medicinal products (HMPs). The quality, including the stability, of HMPs should be ...

EMA: Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

22.02.2011
The European Medicines Agency has published concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: ...

EMA: Public statement on the use of herbal medicinal products containing thujone

22.02.2011
The HMPC prepared a public statement on the use of herbal medicinal products containing thujone, which is a natural constituent of the essentials oils of a number of plants widely used. Thujone ...

EMA: Draft guideline on clinical investigation of medicinal products in the treatment of schizophrenia

22.02.2011
The main requirements for medicinal products developed for the treatment of schizophrenia, with regard to study design, patient population and outcome measures are described. Specific issues, ...

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