The International Conference on Harmonisation has been working for more than a decade to help forge guidelines that reduce costs for the pharmaceutical industry and improve patient safety. Its latest offering is crucial to contract research organisations as they pave the way for the submission of standard-format electronic marketing applications to regulatory bodies.
According to the International Conference on Harmonisation (ICH), the history of medicinal product registration in much of the industrialised world has followed a similar pattern initiation, acceleration, rationalisation and harmonisation.
The realisation that it was important to have an independent evaluation of medicinal products before they are allowed on the market was reached at different times in different regions.
In the USA a tragic mistake in the formulation of a children's syrup in the 1930s was the trigger for setting up the product authorisation system under the Food and Drug Administration (FDA).
In Japan, government regulations requiring all medicinal products to be registered for sale started in the 1950s. In many countries in Europe the trigger was the thalidomide tragedy of the 1960s, which revealed that the new generation of synthetic drugs, which were revolutionising medicine at the time, had the potential to cause harm as well as heal.
Registration controls
For most countries, whether or not they had initiated product registration controls earlier, the 1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products.
The industry, at the time, was becoming more international and seeking new global markets, but the registration of medicines remained a national responsibility.
Although different regulatory systems were based on the same fundamental obligations to evaluate the quality, safety and efficacy, the detailed technical requirements had diverged over time to such an extent that industry found it necessary to duplicate many time-consuming and expensive test procedures, in order to market new products, internationally.
Rising health care costs
The urgent need to rationalise and harmonise regulation was impelled by concerns over rising costs of health care, escalation of the cost of R&D and the need to meet the public expectation that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need.
Harmonisation of regulatory requirements was pioneered by the European Community, in the 1980s, as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonisation was feasible. At the same time there were bilateral discussions between Europe, Japan and the US on possibilities for harmonisation.
The birth of ICH took place at a meeting in April 1990 in Brussels, attended by representatives of regulatory agencies and industry associations from Europe, Japan and USA.
Electronic document guidelines
One of the ICH's most important decisions was reached in September this year when it adopted the final version of the electronic common data technical document (eCTD) guidelines.
These pave the way for the submission of standard-format electronic marketing applications to regulatory authorities in the USA, EU and Japan.
As such they have huge implications for the pharmaceutical industry in general and contract research organisations (CROs) in particular.
Among the first to respond, within weeks, was Parexel International, one of the world's largest biopharmaceutical outsourcing companies.
The company has now signed a collaborative agreement with Datafarm to co-market services related to electronic regulatory submissions.
Under the terms of the agreement, Parexel will offer Datafarm's integrated e-submission solutions in combination with its extensive portfolio of worldwide regulatory services that include strategic regulatory consulting, technical writing and dossier preparation.
Electronic submissions
Parexel believes that this collaboration will benefit clients by combining its expert regulatory consulting services with Datafarm's electronic publishing capabilities to produce reviewer-friendly, easily navigable marketing applications in electronic format for submission to global regulatory authorities. The two have already already collaborated on several projects for clients, resulting in electronic submissions to the US FDA.
"We are pleased to form an alliance with Parexel,“ said Shylendra Kumar, president and ceo of Datafarm. "We believe that this alliance, by leveraging Parexel's broad range of biopharmaceutical services, will provide clients with a core competency of high-quality, flexible and cost-effective services to meet the regulatory requirements associated with electronic submissions.“
