India, China Fall Behind in Preparation for New EU API Rules

07-Apr-2013 - Last updated on 08-Apr-2013 at 11:01 GMT

China and India have more work to do to confirm their API manufacturing sites comply with EU GMP requirements, according to the European Commission’s Pharmaceutical Committee.

In preparation for the July 2 deadline when countries outside the EU have to provide written confirmation of GMP compliance in order to import APIs into the region, the European Commission’s Committee on Medicines released a progress report on where each of the 20 major countries stands in their preparations for adhering to the new rules.

Under the EU's Falsified Medicines Directive, each country has the option to either issue its own “written confirmation” via an appropriate authority or apply to be listed with an equivalent system of supervision and inspection as in the EU. In other exceptional circumstances when it’s necessary to ensure the availability of medicinal products, the need for the written confirmation can be waived by an EU member state if that state has inspected a specific plant, the committee notes.

Both China and India have made “good progress” in preparing to issue written confirmations, with India issuing implementation guidelines for GMP compliance and China announcing it will also issue written confirmations, the committee said. India also previously said it would establish a competent authority to ensure API exporters meet the new EU requirements. The two countries account for 934 API manufacturing sites combined, which is more than 60% of the total sites listed by the European Commission.

The committee cautions that China’s SFDA has already said it would not issue written confirmation for manufacturing sites that are not under its supervision. About 30 of China’s 438 API sites are not under SFDA supervision and the committee says the EMA (European Medicines Agency) will coordinate the inspection of these facilities.

Other Countries Underperforming

Four other countries – Argentina (12 API sites), Malaysia (7 sites), Thailand (6 sites) and Russia (5 sites) – have agreed to provide their own written confirmations but are listed under the category of: “More work needed – in particular by industry stakeholders.” The EU committee does not provide any additional information on the necessary work but it says it is in contact with authorities in all of the countries except Russia.

The US, Brazil, Singapore, Japan, Israel and Australia, meanwhile, all applied for exemption from the rules and the committee notes it will perform an on-site inspection in Japan in mid-April and the US in mid-May to assess their equivalency. Australia’s equivalent assessment is “almost concluded,” the committee adds.

Israel and Singapore, however, were both rejected in their bids for equivalency and will issue written confirmations before re-applying for an exemption. And Brazil has yet to submit the appropriate documentation and will have to issue written confirmations as the equivalence assessment has yet to begin, the committee says.

Switzerland is currently the only country that has achieved the equivalence status.

Update on the Rules

As far as what the new equivalence rules will cover, the Commission also recently updated its questions and answers on the new provisions.

In the Q&A, the Commission clarifies that the written confirmation does not apply to blood plasma. However, processed derivatives of plasma with pharmacological, immunological or metabolic actions “are considered as active substance and written confirmation is thus required.”

In addition, active substances “used for investigational medicinal products or for medicinal products intended for research and development trials are excluded from the rules.”