TRAC Shortlisted for Two TOPRA Regulatory Affairs Awards

The announcement of the contenders for TOPRA’s (The Organisation for Professionals in Regulatory Affairs) Annual Regulatory Affairs Awards was made last week with TRAC shortlisted in two categories. 

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TRAC’s Charity Dinner Raffle Tickets

With just days to go to TRAC’s Charity Dinner, we are selling raffle tickets for the evening’s prize draw to people unable to attend the event. 

We’ve a fantastic collection of prizes to win in the raffle that takes place on the night.  The Charity Dinner, held at Tregenna Castle on Friday 30th September, has a “ten” theme to celebrate TRAC’s decade in business, with a raffle that offers ten opportunities to win a package of prizes based around ten individual themes.

Find out about the prizes and how to buy tickets.
 

TRAC’s Director Is Shortlisted Nominee for London 2012 Olympic Torchbearer

The TRAC office was delighted to discover that company director Sarah Trethowan is in with a chance to carry the Olympic flame for the 2012 London Olympics.

After being nominated by TRAC team member Vicki Kent, Sarah will progress to the next stage of the process where her nomination will be reviewed by one of 12 regional selection panels put in place by The London 2012 Torch Relay Team.

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September's Newsletter

Welcome to September’s newsletter.

We were delighted this month to discover that TRAC has been shortlisted for two of TOPRA's Annual Regulatory Affairs Awards.  Congratulations to the team and good luck for the awards ceremony in November.

This month’s newsletter includes features from 2 members of the Regulatory team.  Firstly, David Cox covers the EMA’s first approval of a Paediatric-Use Marketing Authorisation (PUMA) whilst Graham Donaldson looks into the FDA’s strategic plan to advance its regulatory affairs and improve its future success.

The TRAC team are looking forward to celebrating TRAC’s 10th birthday this week at the Charity Dinner held at Tregenna Castle in St Ives on Friday 30th September.  All profit and proceeds from the raffle that takes place on the night will be donated to the Cornwall 100 Club, part of the Cornwall Community Foundation.  If you can’t attend the event, you can still buy raffle tickets to win some fantastic prizes (see below for more details), but hurry time is running out!

If you need short term support or are looking for longer term solutions please do not hesitate to contact us, we’d be happy to discuss how we can assist you with your regulatory projects.

The TRAC Team

Don’t forget you can join us on LinkedIn or follow us on Twitter.

EMA Approves First Paediatric-Use Marketing Authorisation

Earlier this month the EMA (European Medicines Agency) approved its first Paediatric-Use Marketing Authorisation (PUMA).

 A PUMA is a new type of Marketing Authorisation that can be granted to medicines developed exclusively for use in children.  Aimed at encouraging research into paediatric medicines, a PUMA grants a previously authorised drug, which is now off patent, 10 years of intellectual property protection.

To gain approval the medicine must be developed by following a Paediatric Investigation Plan (PIP), which is agreed by a Paediatric committee and must discuss all paediatric subsets. For more information on the process, please see the EMA website.

 The first drug to receive approval is ViroParma’s Buccolam (midazolam oromucosal solution). In adults, midazolam, as the injectable hydrochloride salt solution, had therapeutic indications for sedation and anaesthesia. In children, Buccolam is a treatment for prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years of age. The solution, which is absorbed through the lining of the mouth, offers a far more appealing delivery route than the current treatment of diazepam suppositories.

The PUMA is one of the ways that the EMA is looking to stimulate research into medicines for children. The need for this is obvious when you consider that in the EU 50% or more of the drugs prescribed to children have never been studied in this population or even for the same indication or disease. 

Another incentive offered is that, once a drug is authorised, if companies include the results of the PIP in the patient information then the patent life is extended by 6 months. This is true even if the tests are negative.

Following the change in legislation that came into effect on 26th of January 2007, all new medicines in development must include the results from studies on children. This is also true when a company wishes to register a new indication, pharmaceutical form or route of administration to an existing drug.

 In October 2010, the EMA announced that it had received its 1,000th application for a Paediatric Information Plan.

See the following link for more information First PUMA approval    

Reviewed by David Cox, Regulatory Affairs Executive

Advancing Regulatory Science at the US FDA

In August the US Food and Drug Administration (FDA) launched its strategic plan for advancing regulatory science.  The plan provides specific details of the agency’s Regulatory Science Initiative, originally released in October 2010.

The strategic plan is designed to keep pace with the increasing complexity and challenge of regulating the vast array of products within the FDA’s remit by applying the best possible science to its regulatory activities.  The FDA believes advances in regulatory science will enable the agency to make decisions and take actions that both support innovation and protect and promote public health.

It identifies eight priority areas where new or enhanced investments in regulatory science research capacity will be essential to the FDA’s regulatory mission success. These address issues that typically extend across several product areas. Within each priority area key scientific challenges and implementation plans have been identified. 

These priorities are in order to:

1. Modernise toxicology to enhance product safety
2. Stimulate innovation in clinical evaluations and personalised medicine to improve product development and patient outcomes
3. Support new approaches to improve product manufacturing and quality
4. Ensure FDA readiness to evaluate innovative emerging technologies
5. Harness diverse data through information sciences to improve health outcomes
6. Implement a new prevention-focused food safety system to protect public health
7. Facilitate development of medical countermeasures to protect against threats to U.S. and global health and security
8. Strengthen social and behavioural science to help consumers and professionals make informed decisions about regulated products

The FDA aims to accomplish this plan by applying its knowledge base, laboratories, scientific computing capabilities, and expertise to these identified areas. It will also work with US and international governmental institutions and academia as well as the private sector. It hopes that the document will also provide a focal point for research and development activities outside of the FDA.

See the following link to read the full FDA Strategic Plan. 

Reviewed by Graham Donaldson, Senior Regulatory Executive