UK takes action to prevent API shortages
pharmafile | June 20, 2013 | News story | Manufacturing and Production |Â Â API, MHRA, shortagesÂ
The UK has unilaterally adopted a policy of allowing imports of active pharmaceutical ingredients (API) on the strength of pharmaceutical manufacturer audits in a bid to avoid potential shortages.
The requirement scales down measures due to come into effect on 2 July that require API importers to obtain written confirmations from the regulatory authority where the supplier is based that the facility making them meets European standards. The new regulations are part of the EU Falsified Medicines Directive (FMD).
The requirement would not be required if the supplier is based in a whitelist of countries deemed to be equivalent to the EU in terms of their regulatory oversight. That applies so far only to Australia, Switzerland and most recently Japan, one of the four largest API suppliers into the EU alongside the US, China and India.
The MHRA’s move comes amid longstanding concerns that shortages of APIs could result if suppliers are unable to provide the required certification by the July deadline, although India’s Central Drugs Standard Control Organization (CDSCO) recently published a list of 57 API suppliers – including some big providers such as Teva, Ranbaxy and Mylan – that have been issued with written confirmations.
Specifically, the MHRA will allow API imports from suppliers whose manufacturing site is not covered by a written confirmation or in one of the countries deemed equivalent, provided the importer has audited the site in the last three months, either directly or via an authorised third-party certification body.
It will also allow the import if the facility is holding a current certificate of compliance with Good Manufacturing Practice (GMP) issued by a recognised national authority or international organisation such as the FDA, the World Health Organization and countries who are members of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
The agency stresses in a notice explaining the decision that it is only considered a short-term measure “in cases where there is an overriding need to ensure continued supply of specific active substances”, although it is trying to encourage other EU member states to adopt the same interim policy.
Towards the end of last year, the Heads of Medicines Agencies (HMA) group published concerns about the implementation of the new rules in an official statement, saying the situation “might endanger public health within the EU due to possible shortages of medicinal products for the European market and consequently become a serious public health risk”.
It is understood that many pharmaceutical manufacturers have been trying to stockpile APIs from non-EU countries in order to cushion themselves from any supply interruptions.
Phil Taylor
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