Europe Makes Manufacturing Compliance an Obligation

European Union legislation now requires that all active pharmaceutical ingredients (APIs) going into drugs sold in Europe meet Good Manufacturing Practices (GMPs). The directive went into effect on Oct. 30, almost 50 years after the U.S. enacted similar rules. But rather than chafing under another regulation, the European Fine Chemicals Group (EFCG), an organization launched a year ago to represent fine chemicals manufacturers, is embracing it.

“We have been pushing for GMPs for at least 10 years and now we finally have them,” says Guy Villax, chief executive officer of Hovione and chair of EFCG’s Pharmaceuticals Business Committee. The industry hopes the standards will ensure quality and level the competitive playing field by curtailing the use of less costly, noncompliant APIs. And by ensuring an API’s composition and purity, the regulations are also hoped to avert public safety issues.

There isn’t yet a system for inspections, however, and different countries’ interpretations of the legislation vary considerably. At the CPhI meeting in Madrid, Villax and EFCG President Heinz Sieger, CEO of Chemie Uetikon, described the next steps needed under the directive to ensure that API sources are both compliant and reliable. “Our continuing lobbying efforts are now trying to influence the ‘fine print’ for how inspections are conducted,” Villax told C&EN.

Although EU officials may inspect API producers, the holder of a drug marketing authorization is responsible for making sure the APIs used meet GMPs. Major pharmaceutical and API producers that have been meeting U.S. GMP standards are expected to see little impact. To help both the industry and regulators, EFCG is providing a simple guide to GMP compliance and a third-party auditing scheme for API producers and consumers.

The group is also conducting a benchmarking survey to assess how ready and equipped EU member state health authorities are to enforce the new directive. EFCG hopes to work with regulators to harmonize and improve the format of inspections and certifications and to better understand inspection triggers and sanctions.

“What you have here is the industry asking the regulators if they are adequately equipped to regulate,” Villax says. “It’s like having the robbers ask the police if they have enough police cars.” And he hopes the next step by the health authorities will be “enforcement, enforcement, and more enforcement.”