EC and FDA Scramble to Set Treaty Guidelines

03 August 1998 00:00  [Source: ICB Americas]

By Sean Milmo

Officials from the European Commission and US Food and Drug Administration worked frantically last week to sort out last-minute differences over a mutual recognition agreement (MRA) on the inspection of pharmaceutical intermediates and active ingredients plants.

The agreement, under which the US government and European Union would accept the validity of each otherÕs inspections, has been dogged by delays since it was first proposed by the TransAtlantic Business Dialogue (TABD), a forum of business and political leaders. They saw the deal as a means of dismantling trade barriers and reducing costs.

The MRA was scheduled to be finalized last year, but it was not formally signed by the US government and the EU until this May. Since then, there have been further hold-ups while the EUÕs 15 member states approve the deal and opposing views are thrashed out on key details.

Last weekÕs discussions between the Commission (the EU executive) and FDA and US government negotiators were about Good Manufacturing Practice (GMP) definitions.

ÒThere are two separate definitions of GMP in the agreement, which we want to merge together into one,Ó says a Commission official. ÒBut the FDA wanted to stick to their own definition, so we will just have to live with two definitions.Ó

Nevertheless, the Commission expects it will soon exchange letters with the US government, enabling the MRA to come into effect in October. There will then be a three-year transition period, so the agreement should start to be fully implemented in 2001.

ÒTheoretically, the transition period can be extended,Ó the official explains. ÒBut this is very unlikely because both sides are now intent on going ahead with the MRA.Ó

The European chemical and pharmaceutical industries hope there will be no further hitches. They support the MRA because it will avoid duplication, eliminate a major technical trade barrier, improve production standards and open the way for a global system to inspect plants that produce active pharmaceutical ingredients (API).

The International Conference on Harmonization (ICH), which sets worldwide standards on the safety and efficacy of drugs, is drawing up GMP guidelines for pharmaceutical ingredients. These could provide the basis for a global system of MRAs.

But API producers in Europe fear that the obstacles to a trans-Atlantic MRA, which have been highlighted during the negotiations, could slow progress during the transition period.

The three-year transition is designed to build confidence in the inspection systems of both sides, with FDA and EU inspectors carrying out joint audits of plants. There is skepticism, however, about whether differences in inspection methods can be reconciled that quickly.

The FDA is worried about the EUÕs decentralized system, under which national authorities audit plants, leading to what the agency claims is a wide variety of inspection standards. FDA prefers a centralized authority or even a scheme under which inspections would be carried out by the more competent EU national authorities.

EU licensing organizations and ingredient manufacturers dislike the FDAÕs ÒpolicingÓ style, which they say intimidates rather than encourages collaboration.

ÒWe would not be surprised if the transition period turns out to be longer than three years,Ó says Matt Moran, vice-chairman of the active pharmaceutical ingredients committee (APIC) of the European Chemical Industry Council (CEFIC).

ÒA number of issues could arise which could result in its extension, such as the need for five-year training programs for inspectors or the necessity for more resources to be put into the auditing system.Ó

The Commission opposes the idea of a centralized EU inspectorate or the exclusion of some national authorities from a trans-Atlantic mutual recognition system. It believes the EUÕs own internal mutual recognition system of national inspections is satisfactory.

ÒThe whole point of the MRA is to have an equivalence of standards, not a harmonization so the EU and the US are having similar inspection systems,Ó says the Commission official. ÒThis is not an exercise to satisfy the FDA. The EU must have a system which meets its own needs.Ó

APIC supports the CommissionÕs stance, believing that intermediate and active ingredient producers ultimately benefit from being able to work closely with national licensing authorities.

ÒMany companies see the audits by their national inspectorates as being an exercise in partnership, with the inspectors providing input on how the manufacturer can improve its operations,Ó says Mr. Moran, an executive with the Irish Pharmaceutical and Chemical ManufacturersÕ Federation (IPCMF). ÒIt helps generate a culture of collaboration rather than providing a system aimed at catching a producer out.Ó

The European Generic Association (EGA), representing both generic drug manufacturers and bulk active producers, many of them Italian, is more enthusiastic about the long-term prospects of a central inspectorate system.

For the latest chemical news, data and analysis that directly impacts your business sign up for a free trial to ICIS news - the breaking online news service for the global chemical industry.

Get the facts and analysis behind the headlines from our market leading weekly magazine: sign up to a free trial to ICIS Chemical Business.

Printer Friendly