IGMPI Approvals & Accreditation : Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India, Approved Training Institute of Food Safety and Standards Authority of India (FSSAI), Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh, Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC)
Trusted by organizations & training participants in over 30 countries. Training | Certification | Education | Research

Sponsors urged by European regulators to publish Clinical trial results


03rd July 2019

The top European regulatory bodies like European Medicines Agency (EMA), European Commission (EC) and Heads of Medicines Agencies (HMA) released a letter to clinical trial sponsors last month. This step was taken to remind them to publish the results of all clinical trials conducted in the EU in EudraCT database.

According to the Clinical Trial Regulation, sponsors of EU-based clinical trials are directed to publish their results within one year of completion and within six months for pediatric trials.

As per EMA, the number of clinical trials registered in EudraCT as of April is 57,687 but only two-thirds (68.2%) of the completed trials have posted results in compliance with the regulation and results of 31.8% of them are still lacking.

77.2% commercial sponsors have posted the results with regulatory compliance whereas the results published by non-commercial sponsors is as mere as 23.6%.

Since September 2018, EMA is also reminding the sponsors of trials with missing results of their reporting obligations.


For further enquiries, write to or call us on:
info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280

Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

Clinical Research Newsletter



Featured Article


GMP: A continous process

Mr Vinod Arora, Principal Advisor, IGMPI

IGMPI Placement Blog



Placement Testimonials



Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like