European Regulatory Requirements and

Transcription

1 Safeguarding public health European Regulatory Requirements and Guidance - Present and Future Ian Holloway IATA WCS 9 March 2010, Vancouver

2 Sections S1 S2 S3 The regulatory framework What regulatory changes are ongoing Future regulatory concerns and impact on aviation Slide 64

3 Section 1 EU regulatory framework Regulations Guidelines are referenced in the are directly legislative framework as the most applicable to appropriate way to complete member states. obligations based on current These are not transposed and ensure uniform application of EC law e.g. EC/726/2004, EC/1902/2006 scientific knowledge e.g. Volume 9 (Pharmacovigilance) and Volume 10 (Clinical trials) Directives are binding on all member states and have to be transposed into national legislation e.g. 2001/83/EC, 2004/27/EC Slide 65

4 Examples of Pharmaceutical Directives Directive 2004/93/EC laying down the principles and guidelines of good manufacturing practice of medicinal products for human use Directive 2001/83/EC, Title VII, on the wholesale distribution of medicinal products for human use Directive 2005/28/EC on the requirements for authorisation of the manufacture or importation of clinical trial materials Directive 92/25/EEC on the wholesale distribution of medicinal products for human use Directives are transposed into Statutory Instruments in UK legislation Slide 66

5 Key GMP and GDP Regulatory Documents Guidelines on good distribution practice of medicinal products for human use (94/C 63/03) download from e ticals/files/e / ol 4/gdpguidelines1.pdf Good manufacturing gpractice guidelines - Volume 4 of The rules governing medicinal products in the European Union Note This is normally called The GMP Guide and is used by regulatory inspectors as the basis of site inspections at manufacturers and contract laboratories download from vol-4/index_en.htm Slide 67

6 Section 2 Current revision of 94/C 63/03 The GDP guidelines are currently under revision The original document dates from 1994 and does not reflect the emerging changes to the distribution industry do not provide industry and regulatory bodies with clear guidance/policy on a number of issues Today s distribution network for medicinal products has become increasingly complex..inconsistencies throughout Member States with regards to management and licensing of activities such as virtual wholesaling and trading/brokering of medicinal products, total or partial outsourcing of the distribution and transportation Slide 68

7 Approach to 94/C 63/03 revision Work stream 1 Work stream 2 Further work (later pending further legal proposals) Focus on review of the guideline and other documents such as WHO, Working Group of Enforcement Officers, PIC/S 2008 seminar etc Will develop wholesale authorisation formats, certificate templates and procedures for inspection, report writing and inspector training Obligations and requirements for wholesalers distributing to third countries, inspection procedures for traders and accreditation for third party auditors Current status (Jan 2010) EMA GMP/GDP Inspectors Working Group - High priority in year plan. Finalise the draft revision and release for public consultation Slide 69

8 ICH initiatives ICH is International Conference on Harmonisation of technical requirements for human use medicines. It brings together the regulatory authorities of Europe, Japan and USA together with experts from the pharmaceutical industry. Purpose is greater harmonisation of guidelines and requirements for registration of pharmaceuticals Q8: Q9: Q10: Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System Quality Risk Management has been incorporated into the GMP Guide. Text is present as Annex 20 (same title) and effective from Feb Work is ongoing to incorporate Q10 material into the GMP Guide. download ICH Q10 pdf Slide 70

9 ICH Q10 - Quality Systems A new tripartite guideline describing a model for an effective quality system needed to establish and maintain a state of control that can ensure the realisation of a quality drug product and facilitate continual improvement over the product life cycle. Will augment (not replace) existing GMPs It is not a replacement for Chapter 1. Focuses on quality systems and complements ICH Q8 and ICH Q9, enabling the realisation of the full benefits of the concepts contained within all three guidelines. Optional model but having a QMS isn t!! Slide 71

10 Planned revision to Chapter 1 of the GMP Guide Incorporation of ICH Q10 principles i on the Pharmaceutical Quality System title now Quality Management System Significant expansion in total content 5 sections to 19! Draft section 1.14 Management of Outsourced Activities and purchased Materials :- Assessing prior to outsourcing..the th suitability and competence. Responsibilities and communication for quality related activities. ities Performance monitoring, review and improvements Monitoring incoming ingredients and materials Also feedback on outsourced activities included in management review of the QMS Also in 1.13 a review of Chapter 7 contractual arrangements to ensure that they are current Slide 72

11 Quality by Design principles are also being incorporated into the GMP Guidelines Key principle is to design quality into products - not to add on at a late stage. From Development to throughout the process! Transport considered as part of product design Much more consideration at the initial registration and development stage A potential manufacturing site may be rejected due to location or poor transport infrastructure Currently transport design is often a retrospective add-on when an established product is moved to a new outsourcing site Slide 73

12 Other planned/ongoing changes to rules and regulations Revision of GMP Guide Chapter 7 (Contract manufacture and analysis) Aim is to improve the advice on outsourcing To develop a new section in the Compilation of Community procedures related to GDP Discussions on minimum standards for transportation have started within European Medicines Agency (EMA). This is expected to be a joint document issued by the Quality Working Party (QWP) and Inspectors Working Group (IWG) download EMA quality guidelines Slide 74

13 Section 3 Future changes likely to impact on aviation The supply-chain contains elements such as wholesalers l which h are subject to regulatory inspection but other parts such as aviation are not examined by regulators and constitute a Regulatory Gap A Regulatory Gap is facilities and systems which could affect the quality or performance of a medicine that are not validated, inspected or documented to normal GXP standards Slide 75

14 Regulators are unlikely to start inspecting Regulatory Gap areas Companies need to close the Regulatory Gap by the use well established techniques such as audit, quality systems, technical agreements and improved systems for deviation capture. The Qualified Person releasing the batch will be increasingly scrutinised by Regulators seeking assurance that Regulatory Gap areas do not pose a risk to the product Development of Chapter 17 will facilitate closing the Regulatory Gap but the Qualified Person will be subject to increasing scrutiny and information requests by regulators. Slide 76

15 Longer term issues which will probably impact on the aviation industry Making the supply-chain robust and preventing penetration by counterfeits. Significant changes planned to Directive 2001/83. Previously unregulated areas such as Brokers to have responsibilities Concerns about radiation from X rays, bomb scans and possibly high-altitude radiation Effect of radiation on medicines especially biologicals? Controlled temperature sea distribution is lower cost and becoming much more available As well as lower cost this eliminates potential air concerns such as ramp handling and flight changeovers Slide 77

16 Summary Changes to both GMP and GDP regulations and guidelines are taking place to reflect outsourcing and globalisation Some elements of the international supply chain are not inspected by Regulators. These are likely to be subject to increasing regulatory scrutiny and companies need evidence to demonstrate conditions are acceptable Concurrent initiatives for anti-counterfeiting and product security will also drive higher controls and expectations on the supply chain Outsourcing and global distribution will continue to increase resulting in increased opportunities for reputable service and equipment providers Slide 78