Pharmaceutical Technologist - January 2008 - (Page 28)

Q&A expects the same quality standards regardless of country of origin. This is in collaboration with other regulatory bodies worldwide. In addition, all products from outside the EU are required to be tested and released upon entry. Certain Eastern European countries are now members of the EU and, as such, are fully subject to EU legislation, as is the UK. response is for companies to develop comprehensive integrated quality systems, including effective technical transfer processes. Gone are the halcyon days when development, active ingredient and finished product manufacture were all conducted on the same site. What do you believe are the real, current supply chain/counterfeit issues? Counterfeit medicines are a current reality and there is every indication that the threat from this illegal activity is growing. The last 4 years have seen 14 detected cases in the UK supply chain, compared with only one in the previous decade. Accompanying this insidious increase has been a move from lifestyle medicines to life-saving medicines. The MHRA has recently published a comprehensive anticounterfeiting strategy and has been particularly effective, through rigorous surveillance and enforcement programmes, at detecting and prosecuting perpetrators. Last year saw a number of convictions with prison sentences of up to 6 years. Clearly, the availability of products through the internet can also represent an additional threat. The MHRA is actively preventing illegal activity on the internet and seeking to alert the public to the risks. In association with the UK Government and with other regulatory and health bodies such as the Royal Pharmaceutical Society of Great Britain (RPSGB), the MHRA is working to ensure that there is proper guidance to support the safe purchase of medicines over the internet. In addition, maximum publicity is sought for all enforcement or compliance action taken against illegal UK based websites to ensure that the public are made aware of the threats posed by such illegal supply and are provided with appropriate guidance on minimizing this risk. Enforcement initiatives include Internet Days of Action and specialist search tools which are configured to continuously monitor the internet for websites hosted in the UK, or fulfilling orders from within the UK that are supplying suspicious product. The MHRA is particularly active in seeking to bring perpetrators to justice. How big a job does the MHRA actually have? The MHRA is the Government Agency with primary responsibility for ensuring that medicines and medical devices work, and are acceptably safe. We discharge this responsibility through involvement in all stages of the product life cycle, from preclinical studies on drug substances and the approval and inspection of clinical trials, to the licensing of medicines and their manufacturers and distributors and post marketing vigilance. This is, of course, an enormous job through which, working together with other EU member states, we are able to safeguard UK public health. Is the MHRA adequately resourced? In the MHRA we are continuously reviewing our resources in line with our responsibilities. I am pleased to report that there have been demonstrable improvements in the performance of the aspects of the MHRA’s assessment work which suffered during the introduction of our new integrated computer system a year or so ago. For example, the time taken to complete the assessment of applications for new marketing authorisations has halved in the past 18 months. And for simple notification changes, the processing time is now back in line with our business plan targets. Under the Government’s better regulation agenda, we are reviewing the level of our regulatory oversight and seeking, where possible, to reduce the burden on Industry and generate internal efficiencies. We have excellent staff who are welltrained and motivated, and are more than capable of rising to future challenges. What is the future of the MHRA? We have recently published the MHRA proposed strategy for the The MHRA is actively preventing illegal activity on the internet and seeking to alert the public to the risks. With regard to APIs, the recently implemented European Commission Directive relating to medicinal products for human use (2001/83/EC, as amended) requires marketing authorization holders to verify the GMP of their API suppliers. The MHRA expect this to be based on supplier audits. In general, dose form manufacturers and importers are taking steps to implement this requirement, although the MHRA will take regulatory action against MA holders and undertake for cause inspections of API manufacturers where necessary. How do you see the industry shaping up in the next 5–10 years? The UK pharmaceutical industry continues to face considerable challenges. Many research-based companies seem to be struggling to produce the blockbuster products that made them so profitable in the past and, consequently, they are now facing increasing cost pressures similar to those that have always confronted generic manufacturers. These cost pressures have the healthy effect of driving efficiencies and process improvements, but, regrettably, they are also fuelling the increasing trend towards moving manufacture out of the UK. This move towards global supply and outsourcing will add increasing complexity to the supply chain to which the only acceptable 28 JANUARY 2008 PHARMACEUTICAL TECHNOLOGIST

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Pharmaceutical Technologist - January 2008 Contents Editor's Comment News Morpheus Market Watch Lagging Japanese Drug R&D Croatia’s Innovation Integrating PAT with Biopharmaceutical Development and Manufacture Q&A

Pharmaceutical Technologist - January 2008

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