Tag: Regulatory

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.

SID & GP took part in the International Conference of Drug Regulatory Authorities

Representatives of the Russian Ministry of Industry and Trade and the State Institute of Drugs and Good Practices participated in the International Conference of Drug Regulatory Authorities (ICDRA).

EU regulators published their work programme for 2019/20

The task force set up by European Union (EU) regulators to better address potential problems with medicines’ supply and to avoid shortages published its work programme for the coming two years.

UK will accept EU-based batch testing of medicines

European pharmaceutical companies will be able to supply their medicines in the UK on the basis of approved batch testing carried out in the EU for at least two years.

EMA and FDA will conduct workshop on PRIME and Breakthrough Therapy schemes

EMA and FDA launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible.

EU and Japan strenghten collaboration on inspections of drug manufacturers

The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites.