Recent News
If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
GVP Guideline - Module XV1 Risk-minimisation measures: Selection of tools and effectiveness indicators
13th June 2013
EMA - Guideline on Good Pharmacovigilance Practices (GVP) Module XV1 - Risk minimisation measures: Selection of tools and effectiveness indicators - Start of public consultation 7 June 2013
Guideline on GVP: Module V1 - Management and reporting of adverse reactions to medicinal products
13th June 2013
EMA - Guideline on Good Pharmacovigilance Practices: Module V1 - Management and reporting of adverse reactions to medicinal products - Revision for public consultation 7 June 2013
Draft EU rules on Clinical Trials
31st May 2013
Draft EU rules on clinical trials of new medicines were endorsed by the Public Health Committee on Wednesday. A regulation designed to encourage research whilst protecting patients' rights is to replace an existing directive with simpler, more uniform rules. The new text makes specific provision for low-risk trials, clarifies the duties of ethics committees and details how to obtain informed consent from patients.
Revised code of GMP for human blood and tissues
22nd May 2013
The Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 references the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 (2013 Code of GMP). These requirements commence from 31 May 2013.
New requirements for active substances imported into the European Economic Area
20th May 2013
The Falsified Medicines Directive 2011/62/EU ("the FMD") modifies EU Medicines Directive 2001/83/EC and from 2ndJuly 2013 introduces new requirements for active substances (ASs) imported into the European Economic Area (EEA) for use in the manufacture of authorised medicinal products.
Scientific Guideline: Guidelines on Good Pharmacovigilance Practices: Module VIII – Post-Authorisation Safety Studies, adopted
2nd May 2013
Scientific Guideline: Guideline on Good Pharmacovigilance Practices: Module VIII – Post-Authorisation Safety Studies, adopted
Scientific guideline: Guideline on good pharmacovigilance practices: Module X – Additional monitoring, adopted
2nd May 2013
Scientific guideline: Guideline on good pharmacovigilance practices: Module X – Additional monitoring, adopted.
EU additional monitoring list for medicines
25th April 2013
The Pharmacovigilance Risk Assessment Committee (PRAC) has published the European so-called ‘mandatory’ list of medicines under additional monitoring.
EMA: Module11 - Pharmacovigilance system master file, adopted
18th April 2013
EMA - Module 11 Pharmacovigilance system master file - adopted. Came into effect 12 April 2013
MHRA: Medicines regulator implements innovative software to analyse risk data and target inspection activity
18th April 2013
As part of its risk-based inspections regime which ensures compliance with statutory obligations relating to medicines the Medicines and Healthcare products Regulatory Agency (MHRA) is implementing new IT software.
World Medical Association's Declaration of Helsinki
18th April 2013
Public consultation opens on WMA Helsinki Declaration. A two-month public consultation on the World Medical Assopciation's Declaration of Helsinki on medical research involving human sujects began on the 15 April 2013 with the posting of a revised version of the Declaration on the WMA website
MHRA prioritises science and research support as part of new corporate plan
15th April 2013
The Medicines and Healthcare Products Regulatory Agency (MHRA) today announced its aim to be a leading regulator on the world stage in supporting science and research as part of its new five-year corporate plan. Alongside protecting and improving the health of millions of people everyday through effective regulation of medical products.
Public consultation on the revision of European legislation on medical devices
9th April 2013
In September 2012, the European Commission published what it thinks the new legislation on medical devices should look like. The countries in the European Union and the European Parliament are now negotiating and agreeing the final legislation.
Medicines and Healthcare Products Regulatory Agency Expands
2nd April 2013
The National Institute for Biological Standards and Control (NIBSC), previously part of the Health Protection Agency (HPA), is now a new centre of the Medicines and Healthcare Products Regulatory Agency alongside the Clinical Practice Research Datalink (CPRD).
National Competent Authorities (NCAs) and European Medicines Agency (EMA) requirements for submission of PSUR for nationally authorised products during the transitional period
2nd April 2013
The document aims at making publicly available the submission requirements of all Member States as regard Periodic Safety Update Reports (PSURs) during the transitional period, starting from July 2012 until 12 months after the functionalities of the PSUR repository have been established and announced by the European Medicines Agency (EMA).
EMA Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period
27th March 2013
Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period.
MHRA Updated information regarding pre-inspection documentation: the SPS vs the PSMF
26th March 2013
Prior to the introduction of the new pharmacovigilance legislation in July 2012, the GPvP inspectorate requested Marketing Authorisation Holders to submit pre-inspection information in the form of a Summary of Pharmacovigilance Systems (SPS) document.
MHRA simplification measures announced following Red Tape Challenge
26th March 2013
The MHRA is today announcing a package of simplification proposals. This follows participation in the Cabinet Office Red Tape Challenge exercise last year.
MHRA: GCP Metrics Reports 2008-2010
19th March 2013
Reports covering the period 1 April 2008 to 31 March 2009 and 1 April 2009 to 31 March 2010 have been added to the Good Clinical Practice section.
EMA: Implementation plan for the introduction of new pharmacovigilance legislation requirements into the product information of centrally approved medicinal products.
18th March 2013
The European Medicines Agency and the Quality Review of Documents (QRD) Group have revised the Human Product Information templates as a result of the introduction of the new pharmacovigilance legislation.
EMA focuses on new legislation, increased efficiency and transparency in 2013 work programme
14th March 2013
The European Medicines Agency has published its work programme for 2013.
MHRA launches an 'Innovation Office' to encourage the development of novel medical products and devices
12th March 2013
The MHRA is launching an 'Innovation Office' to help organisations who are developing innovative medicines, medical devices or using novel manufacturing proccesses to navigate the regulatory processes in order to be able to progress their products or technologies.
The EU GDP Guidelines of 7th March
12th March 2013
New Publication- The EU GDP Guidelines of 7th March 2013 (2013/C 68/01)
Tackling medication errors: EMA workshop calls for coordinated EU approach
4th March 2013
A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medication errors causing harm in Europe.
Launch of consultation on legislation on indemnity insurance
1st March 2013
Department of Health A consultation is launched on legislation that would mean all regulated healthcare professionals have to hold indemnity or insurance to practise. The consultation will run from 22 February to 17 May 2013 on draft regulations on the requirement for all regulated healthcare professionals to hold an insurance or indemnity arrangement as a condition of their registration with the relevant regulatory body.
European Commission consultation paper on the regulation of advanced therapy medicinal products
28th February 2013
The European Commission (EC) is seeking views from stakeholders on the application of the Regulation on advanced therapy medicinal products (Regulation 1394/2007). Under the regulation the Commission is required to assess the application of the Regulation. The Commission has invited comments by 31st March 2013. A copy of the Commission's consultation document can be found here.
MHRA - Risk Management Plans
22nd February 2013
MHRA - Risk Management Plans: Guidance on submission of risk minimisation materials. Educational materials for health professionals and patients are ofetn required in the Risk Management Plan for a new product and it is a requirement that the UK version must be submitted to the MHRA for review prior to issue.
MHRA - Launches campaign to urge pharmacists, GPs and the public to report any suspected side effects from medicines
1st February 2013
The MHRA today launched a public health campaign in partnership with pharmacy organisations to highlight the need for the public to report any suspected side-effects from medicines through the yellow card scheme
EMA - The Committee for Medicial Products for Veterinary Use (CVMP) has published a concept paper on limits for genotoxic impurities
31st January 2013
In the abscence of guidance on limits for genotoxic impurities in veterinary medicinal products, the CVMP recomends the development of a guideline to describe a practicle approach on how to deal with genotoxic impurities, taking account of both target animals and consumer safety. This document will have to define the type of information required for assessment and how to perform the risk assessment according to the type of genotoxic impurities.
Revision of the EU Commission Guidelines on Good Manufacturing Practice
30th January 2013
The European Commission has launched the public consultation of revised guidelines on good manufacturing practices.
EMA - Guideline on Good Pharmacovigilance Practices Module XV - Safety Communication
28th January 2013
EMA - Guideline on Good Pharmacovigilance Practices (GVP) Module XV - Safety Communication came into effect 24 January 2013. The final Module X will published later in 2013.
Final Rule: Current Good Manufacturing Practice Requirements for Combination Products
23rd January 2013
FDA Current Good Manufacturing Practice Requirements for Combination ProductsThe Food and Drug Administration (FDA) is issuing this regulation on the Current Good Manufacturing Practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products.
NIHR launches new Clinical Trials Toolkit for researchers
23rd January 2013
The National Institute for Health Research (NIHR) has launched the new Clinical Trials (CT) Toolkit website. This innovative website is designed to help researchers navigate through the complex landscape of setting up and managing clinical trials in line with the regulatory requirements
New RSS Feeds
15th January 2013
If you have previously subscribed to the BARQA RSS feeds, please ensure you update your reader with the new RQA links.
EMA ICH E2C Periodic Benefit-Risk Evaluation Report
9th January 2013
The Periodic Benefit-Risk Evaluation Report (PBRER) described in the guideline is intended to be a common standard for periodic benefit-risk evaluation reporting on markedted products (including approved drugs that are under further study) among the ICH regions. The guideline defines the recommended format and content of a PBRER and provides an outline of points to be considered in its preparation and submission.
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