MHRA’s Black Triangle Report

In United Kingdom, there are certain drugs in which although they were granted marketing approval by the Medicines and healthcare product regulatory agency (MHRA), they need to be closely monitored, since limited information were available about these drugs.

One of the key reasons attributed to this may be, less subjects being enrolled in the clinical trials, short therapy duration etc.…thus, in order to identify rare adverse reactions, effect of the drug in different populations or effect of the drug under different co-morbidities, such drugs are tagged with an inverted black triangle (▼) on their package insert, to ensure that these drugs are intensively monitored.

The Commission on Human Medicines (CHM) and MHRA encourages expedited reporting within 15 calendar days of all such drugs with an inverted black triangle symbol if, found to have caused serious or non-serious adverse drug reaction.

You may find the black triangle drugs at the Electronic Medicines Compendium, British National Formulary, Nurse Prescribers’ Formulary etc.… A black triangle symbol may be assigned to any new active drug / vaccine or even a Biosimilar (Biosimilar are similar biological therapeutic products). Black triangle is not restricted to only drugs, it may also include new route of administration, new drug delivery systems or even new patient population.

Black triangle drugs are reviewed every 2 years by the MHRA and monitoring black triangles reports helps in identifying benefit risk profile of drug and unrecognized adverse effects.

Reference:

·         List of medicines under additional monitoring, European Medical Agency (url: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp&mid=WC0b01ac058067c852 )

·         EMC (https://www.medicines.org.uk/emc/ )

Brought to you by:

Cliniminds- Leaders in Pharmacovigilance and Clinical research training. Our training include hands on experience on pharmacovigilance software (Argus safety). To catch with recent updates on pharmacovigilance, check out our newsletter at Cliniminds Pharmacovigilance page (www.cliniminds.com)

How pharma data / business analytics are helping pharmaceutical companies?

Case Study:

A top pharmaceutical company was interested to develop a medicine for diabetes, and for which it wanted to asses and identify attractive patient segments.

Approach

Secondary research was undertaken to understand current diabetes treatment guidelines and therapy landscape, to identify patient segments. Following this trial analysis was undertaken to identify upcoming trends and molecules in different patient segments of diabetes. The molecules and trends were further analyzed to ascertain their expected relevance on the diabetes landscape through clinical data and benchmark analysis. Key trends analyzed during the study were related to epidemiology, pricing, regulatory activities, and market access regulations across geographies. These findings were further validated through an intense primary research involving key opinion leaders, payers, physicians and regulatory bodies. The all inputs from primary and secondary research with collated together and analytical tools, such as PESTLE, SWOT, ANSOFF and 5 WHY’s were used to generate insights out of the information. Final report clearly laid out “WHERE TO PLAY” and “HOW TO PLAY” strategic options within diabetes.

Outcome

Project helped client to clearly understand the development opportunities within diabetes and design development plan for molecule as per plan.

About Cliniminds

Cliniminds is India’s leading Health Sciences Education, Training & Consulting organization offering specialised program in pharmaceutical data / business analytics, and other health sciences programs. All Cliniminds programs are linked with job placements. Cliniminds has trained and placed over 6,500 professionals in the health sciences domain.

For more information, please call 9810068241 or mail at info@cliniminds.com; www.cliniminds.com