Tag: Regulatory

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 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...

First Details of NHS Long Term Plan

Long-awaited details of the NHS Long Term Plan - which is to be funded by a government investment of £20.5 billion a year in real terms by 2023/24 and aims to transform patient care while spending tax...

EMA released its draft of ‘Regulatory Science to 2025’

European Medicines Agency has published its draft of strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science.

FDA Recommendations for Controlling the Risk of Contamination of Blood Platelets

With the current document "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion", the FDA ...

‘RegLek-2018’ conference participants discussed issues in drug evaluation

On 19th November the scientific-practical conference 'RegLek-2018', was held in Moscow. Participants of the event discussed the modern approaches to drugs expert evaluation.

EMA published new guidance on paediatric medications

european medicines agency
The European Medicines Agency (EMA) has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population.

SID&GP discussed Russian legislation harmonization with EAEU law

The Director of FSI "SID&GP" took part in the round-table discussion on the topic "The issues of Russian legislation harmonization with EAEU law".

European Commission released action plan on paediatrics

The European Medicines Agency and the European Commission’s Directorate-General for Health and Food Safety have published a joint action plan to support the development of medicines for children.

EMA launches a new version of its website

The European Medicines Agency (EMA) has launched a new version of its corporate website. The website has a number of new features to improve user experience.