Better regulation is an important Government agenda aimed at minimising bureaucracy for businesses and front-line staff in the public sector and delivering better public services. BROMI forms an important part of this initiative.
The MHRA is committed to developing regulation which is accountable, proportionate, targeted, consistent and transparent. In order to meet these five principles, for the last year the Agency has been considering how regulation of medicines can be adapted. To take this important initiative forward, the Better Regulation of Medicines Initiative (BROMI) led by the MHRA, has brought together a broad ranging strategy group, which includes representatives from the Proprietary Association of Great Britain (PAGB), the non-proprietary sector, the National Pharmacy Association (NPA), the Department of Health and the Cabinet Office.
Better regulation is an important Government agenda, backed by the Prime Minister and Chancellor of the Exchequer, aimed at minimising bureaucracy for businesses and front-line staff in the public sector and delivering better public services. As part of this initiative, and in response to the Better Regulation Task Force report `Regulation - Less is More’ March 2005 (external link), all Government Departments have drawn up simplification plans. One aspect of the Department of Health’s simplification plan (which can be viewed at on the Department of Health website) is the work of BROMI.
4 November 2011: MHRA stop sending Anonymised Single Patient Reports (ASPRs)/Individual Case Safety Reports (ICSRs) from literature articles to industry
Anonymised Single Patient Reports (ASPRs) and electronic equivalent, E2B Individual Case Safety Reports (ICSRs) sent to industry by the MHRA from ADRs reported in literature articles have been identified by the BROMI Vigilance workstream as an area where significant efficiencies could be made.
As of 24 October 2011, the MHRA updated the logic for how adverse drug reaction reports received are sent out to companies to prevent literature article based ADRs being sent out as ASPRs/ICSRs. Analysis by the MHRA has shown that this will reduce the number of ASPRs/ICSRs sent out to industry by between 33-50%.
The MHRA will be performing an analysis on the reduction in ASPRs/ICSR to calculate estimated savings, and results will be presented at the subsequent BROMI Vigilance meeting and communicated to industry.
Companies should continue to check the list of literature ADRs reported to the MHRA to check whether an ADR from a literature article has already been reported. The following process should be followed:
- Once a literature article reporting an ADR is identified, this should be entered into the marketing authorisation holder’s (MAH’s) pharmacovigilance system for collection and collation of ADR reports.
- Before submission of an expedited report to the MHRA, open the Excel file.
- Check the literature reference in the company report against the literature references.
- If the literature article and patient details can already be identified in the list, the company report should not be forwarded to the MHRA. The MHRA ADR reference should be added to the company ADR documentation and a record added that the ADR has been located on the MHRA literature ADR list with date.
- If the literature article and patient cannot be identified in this list, the ADR should be submitted to the MHRA as per the reporting requirements defined in Volume 9A.
For access to the list, and more information please visit the page below:
Adverse drug reaction (ADR) reports received by the MHRA from literature articles
17 February 2011: Best Practice in Reporting of Individual Case Safety Reports (ICSRs)
We are pleased to announce the release of the 'Best Practice in Reporting of Individual Case Safety Reports (ICSRs)'. The guide sets the MHRA's position on how to code adverse drug reactions (ADRs) to a high-quality standard for entry into our Sentinel database.
Data quality of ICSRs is an important issue that affects all stakeholders, particularly to support accurate detection and analysis of drug safety signals. Furthermore, errors in reports create a large volume of enquiries, resulting in a significant administrative burden for both industry and the MHRA in updating cases. The need to develop a guide was identified as a Better Regulation of Medicines Initiative (BROMI), combining ideas from both the MHRA and UK industry trade associations to address differences that occur in classification and coding practices across companies.
Industry colleagues may be aware that in parallel to producing this guide we have been conducting quality audits on a company by company basis. The selection for audit may be based upon concerns raised through review of reports at signal assessment, compliance data or intelligence gathered from pharmacovigilance inspections.
Companies with a high error rate are invited to discuss the findings. It is hoped the guide will contribute to delivering high standards in classification by highlighting common findings from audits of ICSRs and providing specific examples of good practice. We see the guide as a useful way to improve quality without the need for face to face meetings with companies.
We hope you find this guidance helpful and are able to implement the ‘Best Practice’ within your pharmacovigilance system. If you have any comments or questions, please send them to the Pharmacovigilance Service Desk by e-mail pharmacovigilanceservice@mhra.gsi.gov.uk
Best Practice in Reporting of Individual Case Safety Reports (ICSRs)
(838Kb)
Reports on progress
On 15 September 2009, BROMI published its fourth report on progress:
Better Regulation of Medicines Initiative (BROMI): Fourth report on progress (182Kb)
This report outlines further progress since the third report and developments include:
- updated Variations Regulations which will come into force on 1 January 2010
- the success of BROMI at the National Business Awards in November 2008
- the agreement of the third party pre-approval scheme for changes to pack design for patient information as a mainstream procedure
- the exciting initiatives that are moving forward in the pharmacovigilance work stream.
On 8 May 2008, BROMI published its third report:
Better Regulation of Over-the-counter Medicines Initiative: Third report and recommendations (133Kb)
This report outlines further progress since the third report and developments include:
- a self-certification scheme for certain minor changes to labeling and patient information leaflets rolled out to the prescription only (POM) sector from 1 November 2006 and the quality audit system has moved from 100% to 10%
- a pilot is underway to assess the feasibility of MA holders working together to produce a common PSUR for the same active substance through a work sharing scheme
- a streamlined process for processing applications for copy licenses under Article 10c of Directive 2001/83/EC (as amended) went live on 1 February 2007 and is being monitored
- a mechanism has been implemented to allow roll over of pending variations from the old to the new licence following a change of ownership application, including the roll over of Periodic Safety Update Reports (PSURs) and renewals.
On 11 December 2006, BROMI published its second report:
Better Regulation of Over-the-counter Medicines Initiative: Second report and recommendations (114Kb)
This report outlines further progress since the first report and developments include:
- wider roll out of the product information self-certification scheme to the prescription-only medicines (POM) sector
- work on the development of a code of practice on pack re-design outlining a self-certification model for non-statutory packaging information
- initiation of a review of the medicines statutory label warnings
- progress on the second work stream in relation to variations, copy licences and change of ownership applications
- identification of a third work stream in relation to pharmacovigilance requirements.
The first report of BROMI was published in May 2006:
Better Regulation of Over-the-counter Medicines Initiative: First report and recommendations (108Kb)
BROMI Variations - Joint MHRA/Industry Training Day - 8 May 2008
The presentations from the above event are now available:
- Introduction to BROMI - June Raine
(19795Kb) - Better Regulation - Chris Horsey (254Kb)
- BROMI Industry Perspective and Best Practice - Helen Darracott and Gill Peckham (249Kb)
- BROMI Variation Procedure - Anne Ambrose (506Kb)
- BROMI Variations Overview Training Presentation (242Kb)
- Case Studies Session presentation (939Kb)
Additional guidance:
- BROMI eSubmissions - Case study using the MHRA Portal - Tesfa Rodway (2738Kb)
- Acknowledgement letter
(122Kb) - Non acceptance letter (122Kb)
- Variation application form - Company address change (10878Kb)
- Variation application form - Add pack size (8903Kb)
National informed consent ('simple abridged', Article 10c) applications
The process for approval of national marketing authorisation applications submitted under Article 10c of the Directive (‘simple abridged applications’) has been reviewed within BROMI. Further information is available in the section below:
National informed consent ('simple abridged', Article 10c) applications
The following presentation was presented at the 2008 MHRA Annual Conference. It highlights the most common deficiency areas related to BROMI simple applications
Better Regulation of Medicines Initiative (BROMI) simple applications (831Kb)
Variations processing
Proposals have been developed to move towards a self-certification model for certain Type IA variations and to follow an expedited process for certain Type IB and Type II variations. To support this new way of working criteria and conditions for national procedures have been developed. Further background and information can be found below:
BROMI Dossier Requirements for Type IA and Type IB UK National Notifications - Version 2.1 (615Kb)
BROMI Dossier Requirements for Type IA and Type IB UK National Notifications - Version 2.1 (1013Kb)
A pilot study was undertaken with a limited number of companies from 1 February 2007 to 31 January 2008 to trial the scheme. Once it is fully utilised it is estimated that 80% of national Type IA variations could be self-certified by the marketing authorisation (MA) holder. The scheme is now available to all MA holders and further information on submission of applications can be found below:
Submission of BROMI Notifications – Key Points (41Kb)
The following letter was sent to marketing authorisation holders in April 2008, giving an update on the progress made in relation to the voluntary BROMI variations scheme, and reminding them of their responsibilities should they choose to use the scheme:
Letter to marketing authorisation holders (23 April 2008): Better Regulation of Medicines Initiative (BROMI) - Variations Scheme (39Kb)
Improvements in Detailed Descriptions of Pharmacovigilance System (DDPS) assessments
A new system for the processing of the Detailed Descriptions of Pharmacovigilance System (DDPS) module 1.8.1 of Marketing Authorisation Applications (MAAs). This new system is a result of the many improvements discussed by the Pharmacovigilance sub-group of BROMI.
This new process will take effect from 22 June 2009, and further information and frequently asked questions can be found in the following document:
Improvements in Detailed Descriptions of Pharmacovigilance System (DDPS) assessments (48Kb)
Once you have been issued with an approved DDPS registration number, please use the following template for all future MAAs:
DDPS amendment template (76Kb)
If there are any questions about this new BROMI DDPS process, please email BROMI.DDPS@mhra.gsi.gov.uk
BROMI PSURs
Following a successful BROMI pilot a new self-certification scheme for PSURs is available. Self certification will only apply to purely national authorisations (ie products authorised through MRP and DCP will be excluded) of well established medicines. For the purpose of self-certification of national PSURs well established medicines are defined as actives which have been internationally approved for more than 15 years, do not have black triangle and the safety profile is well known.
If all the criteria (see below) apply the self-certification can be submitted. Some spontaneous reports may have been received during the reporting period however these may not represent a new safety signal. Therefore in these circumstances these PSURs could be self-certified.
1. The active is well established.
2. There are no ongoing safety issues.
3. The product information is up to date or a variation to update in line with brand leader will be submitted within three months
4. The product is not part of the EU PSUR work sharing scheme.
5. There is no Risk Management Plan for the product.
6. No signals have been generated as result of information in the PSUR.
A PSUR application should be submitted according to the usual routes. Please clearly state in the reason comment that it is a BROMI PSUR. The completed letter template should then be submitted in place of the PSUR.
BROMI PSUR Self Certifcation Template (30Kb)
BROMI Renewals
Following a successful BROMI project new procedures have been put in place for national renewals. This involves a reduced submission whereby information that is currently held on the Sentinel database may be omitted from the consolidated renewal file (see list below). In addition applicants are required to submit a cover letter which includes a checklist. This will enable us to channel the renewal application to the appropriate assessment team and expedite assessment.
You should submit your national renewal through the portal in the usual manner and include the completed letter template (see link). The following documents may be omitted from the consolidated file if they are the same as previously advised and no changes are proposed:
- Details of contact persons
- Chronological list of variations
- Current Summary of Product Characteristics, labels and leaflets
- Authorisations/GMP Certificates for manufacturing sites
- Declaration from a QP that the active is manufactured in accordance with GMP.
You are expected to check the information held on RAMA. Please note that details of any errors or anomalies that you may identify in the licence data held on our systems should be sent to the Data Review Team at DataReviewTeam@mhra.gsi.gov.uk. If you do not have access to RAMA please submit the documents but still use the letter template.
BROMI renewal Letter Template (46Kb)
MHRA key BROMI contacts
| Information workstream | Jan MacDonald 020 3080 6267 |
| Authorisation workstream |
Variations Copy licences Change of ownership |
| Vigilance workstream | Mick Foy 020 3080 6633 |
