Common Technical Document (CTD)

The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference on Harmonisation (ICH).

Orphan Drug Designation (ODD)

Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or diagnostics for rare diseases.

Paediatric Investigation Plan (PIP)

A number of regulatory provisions, structures and procedures aim at increasing the development of medicines for use in children.

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.

Pharmaceutical Establishment License (PEL)

Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to certification by regulatory authorities.

Marketing Authorization Application (MAA)

The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks.

Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives

Orphanet Journal of Rare Diseases

There is growing recognition that the current research-and-development (R&D) and innovation-regulation ecosystem could be made more efficient to stimulate and support access to innovative therapies for those patients with rare, life-threatening diseases for which there are no adequate licensed therapies.

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.

The proposed EU IVD Regulation and its impact on companion diagnostic development

SCRIP Regulatory Affairs

Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news.