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Within the rules

Understanding regulatory requirements is vital in the race to market

A road sign indicating a speed limit of 15 kphIn today's competitive environment, reaching the market faster is critical to a medicine's – and hence the company's – success. Understanding the changing regulatory and health technology environment can help companies to secure regulatory or pricing approval as speedily as possible for new medicines.

Clinical trials
Clinical trials are becoming more global in nature as pharmaceutical companies aim to undertake studies that will cater for all markets, as much as possible. Both regulatory requirements and health technology outcomes need to be considered when designing global trials.

When developing a global study programme, the challenge is to try and meet the requirements of regulatory agencies which may vary in clinical practice, ethnicity and disease definitions differing between regions.

Another important consideration is secure pricing and reimbursement approval in each country. As we move to a more global scenario for clinical trials, there is the possibility that a patient population in a specific country will not have been involved in the trials. So if a study had not been carried out in France – because no trials were included in that country as part of the global programme – how will the French pricing and reimbursement authority regard this when it comes to reimbursing that medicine? This issue also has the potential to impact marketing authorisation approval and the EMEA has issued a position paper indicating the challenges and applicability of non-EU patient data being applicable in the EU population.

Critical evaluation
There is now more critical evaluation and attrition earlier in the development cycle and this can prevent unnecessary spending in the later stages. You must ensure that medicines have the  best possible chance of a positive benefit/risk ratio and that there is good rationale for development – such as market, patient and medical need. You also need a good understanding of competitors. It is important that your regulatory colleagues are involved at this stage so that regulatory issues that might impede the medicine's progress can be taken into account as early as possible.

Armed with the information you provide, regulatory staff will then approach the regulatory agencies to seek scientific advice. This helps ensure the trials will meet their needs and requirements and also the needs of national bodies such as the National Institute for Health and Clinical Excellence (NICE) in the UK. Despite all this preparation, the regulatory landscape can be a moving target and may change before you file for approval.

Clinical endpoints
The clinical targets to demonstrate efficacy of newer medicines are more complicated and, therefore, clinical trial design is becoming increasingly complex – in terms of selecting and achieving the primary endpoint. It is critical that endpoints are agreed with regulators in such instances before embarking on phase III trials, because published guidance may not be available for new mechanisms of action and complexity makes it difficult to demonstrate efficacy.

Safety issues on any product also affect the availability of any medicine and benefit/risk is similarly difficult to demonstrate with new chemical entities – perhaps explaining why few are registered each year.

Paediatric medicines
There has been much development around paediatric legislation in the past five years and we now have a specific new European committee – PDCO. There are incentives in Europe and in the US to develop paediatric indications for existing medicines. All new medicines must have a paediatric development plan, unless exempt, so we must bear this in mind when we develop programmes for the adult population.

This is a serious and global problem that can cause significant patient safety issues as well as threaten brand integrity and increase the number of costly product recalls.

New legislative proposals are going through the European Commission that will help improve the integrity of the supply chain. Those in regulatory affairs have worked closely with marketing colleagues to analyse problems and assess the impact, providing feedback to consultations on these proposals.

There are already great initiatives in place – such as high-profile police raids undertaken on the same day in a number of countries highlighting the issue to consumers through media coverage. Working internationally, it is crucial that we have a common vision and purpose. The messages are that purchasing medicines via internet sites without a doctor at the other end is illegal and a real threat to health, and that prescription medicines should be prescribed to patients by a doctor, as they are best placed to access benefit/risk for individual patients.

There are more mechanisms now in place to recognise and deal with this issue – particularly in the UK where there have been significant numbers of counterfeit medicines discovered in the legitimate supply chain since 2004 thanks to the work of the MHRA and industry. Appropriate legal action continues to be taken.

In this kind of environment, pharmacists are being encouraged to check from whom they get their supplies. Direct-to-pharmacy supply from some companies has also helped to strengthen the integrity of the supply chain.

Marketing departments often focus on the medicine's attributes that will lead to a commercial advantage of specific products. However, if revenue is being eroded by a lack of operational compliance on existing medicines, then the overall effect could be neutral or worse. Regulatory affairs teams can help protect revenues through renewals and variations such as those relating to chemical manufacturing and labelling. They can also work with the supply chain to ensure stock levels are maintained.

Pharmacovigilance legislation has changed significantly over the past five years and there are more revisions to come. Many of the changes in pharmaceutical legislation have been triggered by safety-related issues. We all need to keep abreast of these changes and keep up to date on training, as all pharmaceutical companies are inspected on pharmacovigilance as well as other regulatory activities such as good clinical practice and good manufacturing practice.

Building experience
Marketers might want to consider a secondment in regulatory affairs to better understand this role. To be successful in a pharmaceutical company you need to be able to develop transferable skills. A better appreciation of regulation could give a marketer an edge.

At Pfizer we keep our colleagues informed as to how the regulatory affairs department adds benefit and protects patients and adds value to the business through enhancing and protecting revenues. We issue a weekly bulletin to inform our colleagues how we have improved either Pfizer's or the industry's reputation through our work. Working together we can successfully deliver on regulatory strategies that are interlinked with our business needs and these will protect patients, as well as improving millions of lives around the world.

Upcoming event
The EMEA joint meeting with The Organisation for Professionals in Regulatory Affairs (TOPRA) entitled 'Evolution to the Next Step – The Needs of the Future?' takes place at East Wintergarden, Canary Wharf, London, UK on December  1–2, 2009. Its aim is to provide practical insights into the workings of the EMEA, bringing together regulatory personnel from pan-European national agencies and industry to share knowledge relating to EMEA-co-ordinated applications. Hot topics at the conference include:
• The European Commission communication    and pharma package – progress to date
• Pharmacovigilance and risk management
• Working internationally
• Reacting and planning for change – EMEA restructuring
• Paediatrics – clinical studies
• Clinical trials variations and the Committee for Medicinal Products for Human Use (CHMP).

The Author
Dr Zubair Hussain is head of country regulatory affairs for Europe, EEA, Australia & NZ at Pfizer's Worldwide Regulatory Affairs and Quality Assurance division (WRAQA), and head of worldwide regulatory strategy at Pfizer. He is also president-elect of TOPRA
To comment on this article, email

24th November 2009


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