Pharmaceutical Regulations Primer

(Regulations for non-Pharmaceutical Professionals)

11/04/23 (C) Quantum Pharma Consultancy Ltd

What does this game cost ?

• Cost of developing a new medicine $1.3 billion• Submissions to FDA down in 2013 (32) compared to

2012 (41) trend is 35 per year – approvals

• http://uk.reuters.com/article/2013/12/30/pharma-approvals-idUKL2N0K50J420131230#!

11/04/23 (C) Quantum Pharma Consultancy Ltd

Origins of cost

• Discovery of the New Chemical Entity• Regulations– Product development and Product Licences– Manufacturing licences and product maintenance

11/04/23 (C) Quantum Pharma Consultancy Ltd

Why regulate ?- The origins of UK regulation

• Safety – Thalidomide early 1960’s (approx 10,000 children born with ‘phocomelia’ – deformed limbs)

• Quality – Devonport Incident 1968 (Dextrose solution not properly sterilised. 5 deaths)

• Medicines Act 1968 – creation of the medicines commission, introduction of ....... licensing of medicinal product manufacture, procurement, export and sale. Regulation of advertisements.

11/04/23 (C) Quantum Pharma Consultancy Ltd

Current EU Regulation

• ie Safety, Quality Efficacy.

• European Union– Directive 75/318/EEC of 20 May 1975 : analytical,

pharmaco-toxicological and clinical standards and protocols re the testing of proprietary medicinal products

– Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (cGMP)

11/04/23 (C) Quantum Pharma Consultancy Ltd