News
URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 27, 2015 concerning position of Coordination Group for the Mutual Recognition and Decentralised concerning the introduction
30.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 27, 2015 concerning position of Coordination Group
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URPL: Communication to the Healthcare Professional for changes in the use of the medicinal product Mucofluid in children and adolescents
30.04.2015
Communication to the Healthcare Professional for changes in the use of the medicinal product Mucofluid in children and adolescents. ...
GMP: FDA finalizes Guidance on Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
23.04.2015
In June 2014, the FDA published a \"Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant
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GMP: Guideline to Register as a Broker of Medicinal Products
23.04.2015
All Stakeholders dealing with Medicinal Products need to be registered and have to comply with GDP requirements. According to the definition a broker is involved in independently selling or
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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
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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
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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
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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
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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
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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
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