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Pharmaceutical Regulations Primer (Regulations for non-Pharmaceutical Professionals) 12/10/2014(C) Quantum Pharma Consultancy Ltd.

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Presentation on theme: "Pharmaceutical Regulations Primer (Regulations for non-Pharmaceutical Professionals) 12/10/2014(C) Quantum Pharma Consultancy Ltd."— Presentation transcript:

1 Pharmaceutical Regulations Primer (Regulations for non-Pharmaceutical Professionals) 12/10/2014(C) Quantum Pharma Consultancy Ltd

2 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 Submissions to FDA down in 2013 (32) compared to 2012 (41) trend is 35 per year – approvals rma-approvals-idUKL2N0K50J #! rma-approvals-idUKL2N0K50J #! 12/10/2014(C) Quantum Pharma Consultancy Ltd

3 Origins of cost Discovery of the New Chemical Entity Regulations – Product development and Product Licences – Manufacturing licences and product maintenance 12/10/2014(C) Quantum Pharma Consultancy Ltd

4 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. 12/10/2014(C) Quantum Pharma Consultancy Ltd

5 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) 12/10/2014(C) Quantum Pharma Consultancy Ltd


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