Aktualności
FDA: Draft Guidance: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
12.12.2013
Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and
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EMA: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases
12.12.2013
Vaccine pharmacovigilance has been defined by the CIOMS/WHO Working Group on Vaccine Pharmacovigilance as the science and activities related to the detection, assessment, understanding and
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EMA: This concept paper is concerned with the revision of the clinical and non-clinical sections of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registration application for traditional herbal medicinal pr
05.12.2013
This concept paper is concerned with the revision of the clinical and non-clinical sections of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a
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EMA: Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products
05.12.2013
This reflection paper concerns the use of recycled/recovered solvents for extraction of herbal substances in the manufacture of herbal preparations for use in herbal medicinal products (HMPs)/
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EMA: World AIDS Day 2013 – Revised guidance to facilitate development of new medicines
05.12.2013
The document provides a new definition of populations included in clinical trials, moving away from a focus on treatment history (distinguishing between treatment-naïve and treatment-experienced
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GMP: Risk Assessment for ascertaining GMP for Excipients
05.12.2013
The EU has published the comments received from the industry regarding the publication of the draft guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing
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EC: Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use
28.11.2013
The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994. Revised guidelines were published in March 2013 in order to take into account recent advances in practices
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EMA: Draft guideline on the adventitious agent safety of urine-derived medicinal products
28.11.2013
Human urine is used to prepare several products indicated in the field of endocrinology, such as human chorionic gonadotropin (hCG), human menopausal gonadotropin or menotropin (HMG) and
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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning conveying applications regarding serious adverse reaction of medicinal products from Office for Registration to MAH.
28.11.2013
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning conveying applications regarding serious
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GMP: Guidelines on GDP revised
28.11.2013
Only eight months after their publication, the Guidelines from 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use have been revised. ...
