TOPRA: promoting regulatory excellence since 1978

The organisation known today as The Organisation for Professionals in Regulatory Affairs (TOPRA) began as The British Institute for Regulatory Affairs (BIRA).

Nine subscribers who signed our constitution in November 1978 committed the organisation to fulfilling the following objects:

  • To establish professional identity and standards for regulatory affairs personnel in the pharmaceutical and related fields
  • To promote education and science in regulatory affairs
  • To advance the professional competency of its members
  • To promote co-operative relations with other allied organisations
  • To collect and circulate relevant statistics and information of all kinds
These were ambitious goals at a time when ‘product registration’ was poorly understood, geographically fragmented and undervalued; being regarded as a potential barrier to commercial success, rather than an enabler of innovation.

In the following years, these goals have been accomplished, yet remain valid for TOPRA today, where education, co-operation, standard-setting and competence remain at the heart of our strategy. Since 1978, successive leadership teams have developed the tools to promote the professional identity of those working in healthcare regulation, culminating in TOPRA being licensed by the Science Council to award the Chartered Scientist accreditation (CSci) in 2018.

A TOPRA timeline: 1978–2018

1978  Company established; first 'member newsletter'
1979 First Symposium, University of Nottingham, UK 
1980 First Introductory Course, London, UK
1982  First Journal 
1986  Establishment of a European entity 
1989  Postgraduate qualification established 
1992  First Postgraduate Diplomas awarded 
1995  Heron Quays offices opened by Rolf Bass (BfArM)
First PEFRAS (Pan-European Federation of Regulatory Affairs Societies) Congress
1997  First MSc awarded 
2003  BIRA Silver Jubilee celebrations; joint BIRA and ESRA conference, Brussels, Belgium
2004  New constitution to establish the TOPRA name and brand
TOPRA launched in London and Brussels with Daniel Brasseur (CPMP) and Phillipe Brunet (EU Commission)
2004  First edition of Regulatory Rapporteur journal
2004  First joint conference with the EU Commission, Brussels, Belgium
2005  First joint meeting with EMA, Brussels, Belgium
2006  First conference in North America, Washington, DC, USA
First Annual Symposium in partnership with a national agency (MED), Amsterdam, The Netherlands
2010  First Awards for Regulatory Excellence
2014  First online course
2015  Move to current offices at Harbour Exchange
2016  First TOPRA Summit
2017  First conference in India (Bangalore)
2017  Refreshed constitution agreed
2017  Competency framework launched
2017  First conference with HMA, Tallinn, Estonia
2018  Apprenticeship standard (UK) approved
2018  Re-validated 22-module medicines and medical devices MSc launched
2018  First CSci awarded


Q&A with TOPRA's first president

Brian James
To mark 40 years since the British Institute of Regulatory Affairs Constitution was signed – the birth of what is now known as TOPRA – we speak to Brian James, the first President of TOPRA, for his views on how the profession and the professional body have evolved.

Brian James, a PhD graduate in organic chemistry, started his working life at the pharmaceutical company Beechams. After a few years, a position came up in the regulatory department and so he began his career in regulatory affairs in 1978.  He was there to see the profession and the global regulatory affairs professional body grow to what is now TOPRA, the largest professional body for regulatory affairs professionals in Europe, with a steadily growing global membership base. Dr James has been a longstanding member and supporter of BIRA and TOPRA. He was the chair of BIRA from 2003–2004 and was the first President of TOPRA in 2004.

Read the complete interview