Aktualności
EMA: ICH Topic Q3C (R5) Impurities: Guideline for residual solvents
25.03.2011
The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and
...
EMA: Concept paper on potency declaration / labelling for biological medicinal products which contain modified proteins as active substance
18.03.2011
This concept paper aims to provide the rationale for drafting a guidance document for potency assignment of modified proteins for which an International Standard exists or where a clinical
...
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:
...
