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The CPMP Note for Guidance 'Evaluation of anticancer medicinal products in man' (CPMP/EWP/205/95 rev.2, 19 September 2002) presents guidelines on the requirements for authorisation for all anticancer drugs, particularly cytotoxic/cytostatic agents, and is intended to assist applicants in regular and exceptional circumstances (http://www.emea.eu.int/).
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Although this principle is not a legal requirement for the authorisation, it is a general principle for the GMO risk assessment.
The new Implementing Regulation (EU) No. 503/2013 (Implementing Regulation (EU) 2013) describing in detail the risk assessment requirements for pre-market authorisation of genetically modified (GM) food and feed in the European Union became effective in December 2013.
"The PRA is therefore reforming its authorisation requirements for banks in ways that reduce barriers to entry.
Owing to these scaled down market authorisation requirements for biosimilars, it is expected that pharmaceutical companies can produce biosimilars at a lower cost while ensuring their quality, safety and efficacy.
According to the guideline documents, phase III randomised comparative trials are generally required for marketing authorisation.
With a view to the upcoming application for authorisation foreign producers have the opportunity to focus their expenditures on the specific relevant requirements.
The extended authorisation requirement constitutes a ban and at the same time puts economic operators in a position to apply for authorisation (preventive ban with permit reservation).
South Wales and Kent then also asked for authorisation.
In this paper, we propose a trust enhanced distributed authorisation architecture (TEDA) that provides a holistic framework for authorisation taking into account the state of a user platform.
Shortly afterwards there was a rush of applications for authorisation from London councils.
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