Committee for medicinal products for human use (CHMP) guideline on the choice of the non-inferiority margin

2006 ◽  
Vol 25 (10) ◽  
pp. 1628-1638 ◽  
Keyword(s):  
Medicinal Products ◽  
Human Use

Detection of Effects on Male Reproduction—A Literature Survey

1995 ◽  
Vol 14 (4) ◽  
pp. 293-327 ◽  
Author(s):  
Beate Ulbrich ◽  
Anthony K. Palmer
Keyword(s):  
General Purpose ◽  
Literature Survey ◽  
Optimal Combination ◽  
Male Reproduction ◽  
Medicinal Products ◽  
Sperm Production ◽  
Technical Requirements ◽  
Mating Trial ◽  
Weight Analysis ◽  
Human Use

The 1CH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) Guideline for Detection of Toxicity to Reproduction for Medicinal Products, adopted at the Second ICH Conference in Orlando, FL, U.S.A., emphasized the need for research into the suitability of various methods for the detection of effects on fertility in males. The current project was undertaken to compare the efficiency of methods by evaluating reports in the open literature. The results of the examination of 117 substances or substance classes support the view that histopathology and organ weight analysis provide the best general-purpose means of detecting substances with the potential to affect male fertility. Examinations at up to 4 weeks of treatment appear to be as effective as examinations conducted at later times. Mating with females for detection of effects unrelated to interference with sperm production appears to provide an optimal combination because adding other methodologies does not materially improve the detection rate. As to the timing of the mating trial, a 2-week premating period is as efficient as mating at 4 weeks and apparently more efficient than mating after prolonged premating treatment.

The Proposed EU-regulation on Clinical Trials on Medicinal Products: An Unethical Proposal?

2013 ◽  
Vol 20 (4) ◽  
pp. 347-362 ◽  
Author(s):  
Jilles Heringa ◽  
Joseph Dute
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
The European Union ◽  
Medicinal Products ◽  
Member States ◽  
Legal Documents ◽  
Human Use ◽  
Proposed Regulation ◽  
High Level ◽  
Force Member

Abstract The Commission has proposed a regulation ‘on clinical trials on medicinal products for human use’ to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a “high level of human health protection” — required by its legal basis in the TFEU — because it may force Member States concerned to accept a reporting Member States’ approval of — in their estimation — an unethical clinical trial.

Regulatory exclusivities for medicinal products for human use in the EU

2016 ◽  
Vol 5 (1) ◽  
pp. 5-8
Author(s):  
Carla Schoonderbeek ◽  
Bart Jong
Keyword(s):  
Medicinal Products ◽  
Human Use ◽  
The Eu

scholarly journals P59 Assessing medicines for safe use in paediatrics

2020 ◽  
Vol 105 (9) ◽  
pp. e37.1-e37
Author(s):  
Mary Worrall ◽  
Anne Fitzpatrick
Keyword(s):  
European Commission ◽  
Assessment Tool ◽  
New Products ◽  
Daily Intake ◽  
European Medicines Agency ◽  
List Type ◽  
Medicinal Products ◽  
Pharmaceutical Development ◽  
Human Use ◽  
Paediatric Medicines

AimThis service review aimed to reassess and upgrade the ‘New Products Assessment Form’ and to develop an assessment tool in line with European regulations governing paediatric medicines. Many medicinal products routinely used to treat the paediatric population have not been studied or authorised for paediatric use, which means there is widespread unlicensed and ‘off-label’ use of medicines. Medicines deemed safe in adult formulations may not be appropriate for paediatric patients. Medicines must therefore be carefully selected based on agreed criteria including, but not limited to: licensing, excipients, administration, labelling, similarity to other products, safety and handling.MethodA literature review was conducted. Guidance, information, and advice was sought from other healthcare institutions, and European guidelines and directives informing current practise around excipients in paediatric medicines. Pharmacy colleagues were consulted during the development of the tool, and an accessible assessment tool was completed for use in a tertiary paediatric hospital.1–4ResultsThis is the first comprehensive ‘New Products Assessment Form’ in the hospital which complies with the European Medicines Agency (EMA) directives governing excipients in paediatric medicines. The document highlights clearly potential issues and risks associated with product excipients, licensing status, warning label guidance and allows for recording of rationale for the selection of medicines. The ‘New Products Assessment Form’ is intended to highlight potential issues associated with excipients and their associated acceptable daily intake (ADI), but it will also highlight other risks associated with medicines used in paediatrics e.g. inadequate labelling, translation requirements for foreign products, sound-alike/look-alike products, safety and handling, and others.ConclusionThis revised assessment tool has been approved for use in the hospital pharmacy. It will be made available in hospital and community pharmacies on request. Use of the tool should be monitored and audited.ReferencesAnnex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). https://www.ema.europa.eu/en/documents/scientific-guideline/annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human_en.pdf. NPPG Neonatal and Paediatric Pharmacists Group Newsletter No 61 Autumn 2016. Excipients in medicines for children. http://nppg.org.uk/wp-content/uploads/2017/04/NPPG-61.pdfQuestions and Answers on Ethanol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00) https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-ethanol-context-revision-guideline-excipients-label-package-leaflet-medicinal_en.pdfEMA. Guideline on pharmaceutical development of medicines for paediatric use.https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf

scholarly journals Ustalone w Niemczech jednolite ceny dla wydawanych na receptę produktów leczniczych są sprzeczne z prawem Unii.Glosa do wyroku Trybunału Sprawiedliwości z dnia 19 października 2016 r. w sprawie C-148/15: Deutsche Parkinson Vereinigung eVprzeciwko Zentrale zur Bekämpfung unlauteren Wettbewerbs eV

2016 ◽  
Vol 5 (8) ◽  
pp. 122-126
Author(s):  
Tomasz Kaźmierczak
Keyword(s):  
European Union ◽  
The European Union ◽  
Medicinal Products ◽  
Quantitative Restriction ◽  
Court Of Justice ◽  
Equivalent Effect ◽  
Human Use

System of fi xed prices for the sale of prescription-only medicinal products for human use by pharmacies as a measure having equivalent effect to a quantitative restriction on imports. Case comment to the Judgment of the Court of Justice of the European Union of 19 October 2016 in case C-148/15: Deutsche Parkinson Vereinigung eV v. Zentrale zur Bekämpfung unlauteren Wettbewerbs eV

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