Current Clinical Trial Scenario of India

Pharma Bio World

The Indian Clinical Trial Industry, considered as the booming sector and perceived as a potentially upcoming segment, is undergoing turmoil today with a decline of 9.60 per cent in revenues, with further decline because of delay/decreased clinical trial approvals.

Applying for multinational EU Trials can be faster via voluntary harmonisation procedure

SCRIP Regulatory Affairs

Using the voluntary harmonisation procedure to apply for permission to conduct multinational clinical trials across the EU can, in some cases, lead to faster trial authorisations, compared with using the traditional application approach.

US&EU Regulations for drug delivery systems: development considerations for innovate products

SCRIP Regulatory Affairs

Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for biologics and consider the safety, quality and efficacy development challenges for manufacturers.

Considerations on paediatric investigation plans for advanced therapy medicinal products,TOPRA Vol 8, No.10

Regulatory Rapporteur

In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must therefore obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to submitting its marketing authorisation application (MAA).

EU Compassionate use Programme (CUP) regulatory framework and points to consider before CUP implementation

Pharma Medecine Journal

For some patients, compassionate use programmes (CUPs) are the only way to access promising medicinal products that are not yet authorized and for which clinical trials are either not available or in which these patients cannot participate.

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial directive

Pharma Bio World

Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development activities, Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) submissions.

IIR's Partnership Debuts in the Asia Pacific

Applied Clinical trials

Representing more than a third of the world’s population, the Asia-Pacific is an attractive option for cost-effective clinical research regardless of whether the target market for the product is within or outside the region. However, if the clinical research is not conducted efficiently, or to an appropriate level of quality, the anticipated savings can in fact lead to costly mistakes.

Building an affordable innovative drug development chain

Express India

Every time there is a new regulation requested by the government, or generated by the industry needs, our scientific and technical contributions not only help us to remain updated but also aware of the philosophy underlying new regulations. Dr Emmanuelle Voisin, CEO, Voisin Consulting spoke on the trends in regulation and how India fits into her plans to build an affordable innovative chain, from discovery to market.

European Biotech sector struggles to survive funding crisis, Monthly, June 2009

The Center Watch

One in five European small biopharmaceutical companies faces the rick of bankruptcy by the end of 2009. the situation could worsen if the economic downturn continues into 2010, warns the European Biopharmaceutical Enterprise (EBE).

Harmonization Beyond the Implementation of the Clinical Trial Directive


In 1991 the European Commission (EC) initially proposed a clinical trial regulation rather than a directive. Although a regulation typically results in greater harmonization, unfortunately some member states preferred that the EC issue a directive that could be incorporated rather than override existing national clinical trial legislation.