Comments on the EMA draft guideline: Final steps towards a harmonized view between regulators and industry

Author:

Nales Diana A. van Riet,Kozarewicz Piotr,Wang Siri,Saint-Raymond Agnes,Robert Jean-Louis

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference7 articles.

1. European Medicines Agency Committee for Medicinal Products for Human Use & Paediatric Committee & Committee on Herbal Medicinal Products (concept paper only). Guideline on the pharmaceutical development of medicines for paediatric use. Concept paper, first draft, comments, revised draft and overview of comments. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000362.jsp&mid=WC0b01ac0580028eb2 (accessed 05.01.13).

2. EUPFI 3rd conference “Formulating better medicines for children”;European Paediatric Formulation Initiative,2013

3. Guideline ICH Q8(R2) on Pharmaceutical Development;International Conference on Harmonization,2013

4. Directive 2001/83 of the European Parliament and of the Council of 6 November 2011 on the community code relating to medicinal products for human use;European Commission,2013

5. Monograph 0478 on Tablets;European Pharmacopoeia,2013

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