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EMEA: Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies

19.11.2009
This guideline lays down the non-clinical and clinical requirements for monoclonal antibody-containing medicinal products claiming to be similar to another one already marketed, i.e. similar ...

EMEA: Overview of comments received on draft guideline on similar biological medicinal products containing low-molecular-weight-heparins

19.11.2009
The guidance is limited to non-clinical and clinical aspects and does not address the Quality Standard aspects that biosimilar products must adhere to. This may be misunderstood as “the quality ...

EMEA: Draft community herbal monograph

19.11.2009
Draft community herbal monograph on Agni casti fructus Vitex agnus castus L., fructus (agnus castus) ...

EMEA: Reflection paper in the Extrapolation of results from clinical studies conducted outside europe to the eu-population

19.11.2009
This reflection paper, including experience from a sample of applications, shows that in particular extrinsic factors, such as medical practice, disease definition and study population, ...

EMEA: Draft guideline on medicinal products for the treatment of insomnia

19.11.2009
The present document should be considered as general guidance on the development for medicinal products for the treatment of acute and chronic forms of insomnia. Its main focus is on ...

EMEA: Overview of comments received on the draft guideline on the development of New Medicinal Products for the Treatment of Smoking

19.11.2009
SRNT Europe, representing European scientists in the field of nicotine and tobacco research, is concerned that this guideline in its present form will be a barrier to the development of new ...

MHRA: MHRA Patient Information Quality Unit performance figures

19.11.2009
MHRA is now publishing performance figures for the Patient Information Quality Unit (PIQU).This follows feedback from the medicines trades associations that separate metrics are needed to aid ...

MHRA: Guidance published on UK exporting of medicines

19.11.2009
Guidance helping pharmaceutical manufacturers and distributors to meet their obligations about the supply of medicines, has been jointly published today by nine health organisations including the ...

MHRA: Publication of responses to consultation MLX 358 on European Commission proposals on information to patients

19.11.2009
On 10 December 2008 the European Commission published a legislative proposal for the pharmaceutical industry to be able to communicate certain information on prescription medicines directly to ...

MHRA: Updates to BROMI guidance documents added to the Labels, patient information leaflets and packaging for medicines section

19.11.2009
Two updated BROMI guidance documents have been added to the Labels, patient information leaflets and packaging for medicines section. MHRA guidance on changes to labelling and patient ...