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The Global Pharmaceutical Regulatory Environment

Source: Dr Faiz Kermani
Published: 06/01/07
Click here for jobs in Regulatory Affairs

Even if a drug does get through the company’s R&D process it is then subject to the regulatory review process. This final stage of drug development is beyond the control of companies and yet it is the last hurdle to overcome before a drug reaches the market (1). The outcomes of such reviews cannot be predicted, but by planning ahead and seeking good advice on regulatory options and guideline changes, companies can be better prepared. The regulatory review processes employed by different authorities and the amount of time taken up by companies responding to regulatory questions raised during the review are both considered important factors that contribute to differences in review times.

Globalization and harmonization

The pharmaceutical industry operates on a global level. The global rollout of new drugs is becoming increasingly important for companies in order to maximize revenue through the rapid penetration of available markets. Furthermore, this globalization is also being driven by the demand from patients worldwide to gain access to the new treatments becoming available in other regions.

Different events in the US, Europe and Japan led to the idea that an independent evaluation of medicinal products was necessary prior to them being allowed on the market. However, this process remained nationally-based and over time did not reflect the growing international nature of the pharmaceutical industry’s activities (1). Thus much of the regulatory process was being repeated in each of the markets, which led to delays in launching products that would serve an unmet medical need and unnecessary expense and use of resources in satisfying each regulatory agency’s requirements. Since 1991, there has been a move to harmonize the regulatory requirements in different world regions.

Often referred to as simply ICH, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique initiative that seeks to promote greater regulatory harmony between different world regions. Specifically, ICH brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in these three regions to discuss scientific and technical aspects of product registration (1).

ICH is composed of Six Parties, who have direct involvement, as well as three Observers and The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents the pharmaceutical industry at an international level. ICH also has Observers, which are the World Health Organization (WHO), Health Canada, and the European Free Trade Association (EFTA). ICH is operated via the ICH Steering Committee, which is supported by ICH Coordinators and the ICH Secretariat.

Japan’s regulators under fire

The question of access to medicines places a considerable demand on the regulators. One of the aims of the regulatory authorities is to increase the availability of new drugs to patients in their country, but they must constantly be aware of any potential risks to their populations. For example, at the present time the Japanese regulatory authority is under considerable pressure as it has been suggested that patients in Japan have to wait twice as long on average as those in the USA to gain access to new medicines (1). Since 2005, there have been ongoing attempts to reform the regulatory system in Japan.

In March 2005, the Chief Executive of Japan’s Pharmaceutical and Medical Devices Agency (PDMA) admitted some of the failings and promised to address these problems (1). One of the steps taken was to increase the number of staff to handle the increased workload. The PDMA aimed to double its budget and increase review staff to 290 by 2008. Furthermore, the PDMA set a target of processing 80% of reviews within 12 months (apart from stoppages). The agency also believed that pre-submission consultations on trials and data requirements would improve the quality of data submitted to the agency.

Outlook

Different regions continue to have different regulatory requirements and this is an influential factor for companies wishing to operate on a global basis. They have to be proactive in order to make sure that the work they have done in one region will satisfy the regulators in another region. With the constantly changing regulatory requirements keeping up to date is no easy task. Furthermore, it is only through experience that many of the nuances in dealing with different national regulators become known.

References

  1. Pharmbiosys (2007). Pharmaceutical Research and Development in the 21st Century.


Dr Faiz Kermani has several years experience in both academia and the pharmaceutical industry. He has worked in pharmaceutical R&D, pricing and reimbursement, marketing and medical communications. He holds a PhD in Immunopharmacology from St. Thomas’ Hospital, London and a First Class Honours degree in Pharmacology with Toxicology from King’s College, London. He has written extensively on international healthcare issues, and is on the editorial board of a number of publications. In March 2006, he was a delegate on the UK Government’s Trade and Investment Biotech Scoping Mission to China and was a speaker at the subsequent presentation.

You can contact Dr Kermani via jobs@leaddiscovery.co.uk
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