Tag: Regulatory

Regulatory Science Strategy to 2025 in the EU

EMA has published its Regulatory Science Strategy to 2025. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It come...

EFPIA Expressed Concern over New EU Regulation on HTA

In light of the inclusion of the Commission Proposal for a European Regulation on HTA as an AOB at the 9 December EPSCO, EFPIA, representing the research-based pharmaceutical industry operating in Eur...

HPRA Seeks Feedback to Inform Development on Regulatory Plan for 2021 to 2025

Ireland’s Health Products Regulatory Authority (HPRA) is seeking feedback to inform the development of its strategic plan for 2021 to 2025. HPRA wants input on how the sectors it regulates will change...

Swissmedic Creates Signal Notification Form in Change to 2020 Requirements

The Swiss Agency for Therapeutic Products (Swissmedic) has created a signal notification form as part of a change in how it will collect safety data. Starting in January, Swissmedic will ask marketing...

European and Chinese Authorities Talked on Medicine Regulation

European-Commission
The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr. Chen Shifei, visited EMA on 25 October together with a delegation.  The visit took place in the context of...

Pakistan Seek for Help to Regulations Harmonisation with Global Best Practices

Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) is recruiting a consultant to help it harmonize its rules and regulations with international best practices. DRAP wants the consultant to work on areas...

List of Vital and Essential Drugs for 2020 Approved in Russia

drugs
Russian Prime Minister Dmitry Medvedev signed Order No. 2406-r dated October 12, 2019, which supplements the list of vital and essential drugs for medical use (Vital and Essential Drugs) for 2020 with...

New Norms Aimed at Acceleration of Medicines Procurement Procedures Came into Force in Russia

On October 1, a number of amendments to the Federal Law No. 44 “On the contract system” will come into force. The changes concern the acceleration of procurement procedures - including medicines. This...

Changes to the Russian Regulation of Medical Devices Come into Force

medical devices
On August 9, 2019, Roszdravnadzor’s order No. 3239 from April 25, 2019 “On approval of the administrative regulations of the Federal Service for Supervision of Health Care for the provision of public ...

Amendments to Federal Law “On the Circulation of Medicines“ Entered into Force

Russian President Vladimir Putin signed the Federal Law “On Amending Certain Legislative Acts Regarding the Regulation of the Circulation of Medicinal Products for Veterinary Use”. The document is pub...

Experts Call on Paktistan to Reform Pharma Regulatory Framework

Pakistan
Pakistan needs to urgently reform its existing regulatory framework, to unlock the potential of "scale" within the local pharmaceutical manufacturing sector of Pakistan and secure access to global mar...

Relation to Regulatory Specifics of the Pharma Market in Russia and EEU

The new video of TRUBOR ONLINE is prepared in Spanish (with English subtitles) and provides a helicopter view in relation to regulatory specifics of the market access in the pharmaceutical sector in R...

Spanish Medicines Agency to Become Designated against EU’s MDR

The Spanish Agency of Medicines and Medical Products (AEMPS) said Wednesday it has begun the process to become designated as a notified body (NB) against the EU’s medical device regulation (MDR). A...

Updated Obligations for Drug Shortage in Australia

The Australian medicines regulator has updated its guidance on reporting obligations for pharmaceutical companies, mandating confidential reporting of all shortages. The document, published by the ...

China to Ensure Vaccines Safety

China will strengthen management and supervision of vaccines to ensure their safety, the country's top drug regulator said Monday. Chinese lawmakers have finished their first reading of a draft law...

Russia Signed Implementation Drug Labeling System Document

Dmitry Medvedev, The Chairman of the Government of the Russian Federation on 14 December 2018 signed the Orders about implementation in the territory of the Russian Federation the system of monitoring...