EN PL

News

GMP: Recommendations of the EMA for the risk assessment of metallic impurities in approved drugs

23.04.2015
Recently, with the inclusion of the Guideline ICH Q3D in the collection of \"Scientific Guidelines\", the EMA established the deadlines for its entry into force (see our news \"The CHMP adopts the ...

EMA: Draft qualification opinion of qualification of exacerbations of chronic pulmonary disease tool (EXACT), and EXACT-respiratory symptoms measure (E-RS) for evaluating treatment outcomes in clinical trials in chronic pulmonary disease

23.04.2015
The EXACT-PRO Initiative (EXAcerbations of Chronic Pulmonary Disease Tool – Patient-Reported Outcome) brought together clinical, research, methodology, and regulatory experts to develop a new ...

EMA: Medication errors

23.04.2015
Medication errors are unintended mistakes in in the prescribing, dispensing and administration of a medicine that could cause harm to a patient. They are the most common preventable cause of ...

FDA: Risk Evaluation and Mitigation Strategies: Modifications and Revisions

23.04.2015
This guidance provides information on how the FDA will define and process submissions from application holders for modifications and revisions to approved risk evaluation and mitigation strategies ...

EMA: Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)

16.04.2015
Vaccine covers five more types of HPV than previously approved Gardasil vaccine The European Medicines Agency (EMA) has recommended Gardasil 9 (human papillomavirus vaccine) for the prevention ...

EMA: Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

16.04.2015
Regulation (EC) No. 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The ...

EMA: Compilation of individual product-specific guidance on demonstration of bioequivalence

16.04.2015
The general European Union requirements for bioequivalence demonstration are laid out in the Guideline on Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). In addition, the CHMP ...

MHRA: Medicines regulator launches call for evidence on previously licensed oral hormonal pregnancy tests

16.04.2015
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public call for evidence relating to the use of oral hormonal pregnancy tests (HPTs, which are no longer ...

GMP: Revision of relevant PIC/S Guidance Documents in 2014

16.04.2015
Amongst the guidance documents of the European Union and of the US authorities, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) published the revisions of two relevant guidance ...

GMP: Mixing, Diluting, or Repackaging Biological Products - FDA Draft Guidance

16.04.2015
In February, the FDA published a new draft guidance on \"Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application\". Background is the ...