The HMA explained the risk assessment process in a checklist published yesterday to coincide with new rules requiring that all drug actives shipped to the European Union (EU) be accompanied by written confirmation of quality from regulators in the country of manufacture.
The assessments - which are to be conducted by drugmakers whose API imports lack the required documentation - can trigger facility inspections by the European Medicines Agency (EMA) if they meet the following criteria:
– Drugmakers need to state clearly why no written confirmation has been issued.
- They also need to specify how much of the API they have in stock
- The indication of the drug in which the API is used should be provided
- Drugmakers are also required to say if any alternative medications are available.
The HMA - which is made up of the heads of regulatory agencies in the European Economic Area – said the document is "intended to promote common expectations and common approaches by Member States regardless as to the points of control or verification as decided upon by Member States in their transposing legislation and which may differ between Member States.
“The actions described for importers should avoid difficulties in the situation where the new legislation is not yet fully transposed by all Member States, without prejudice to provisions present in national legislations."
The idea of asking importers to conduct risk assessments is not new. A few weeks back the UK Medicines and Healthcare products regulatory agency (MHRA) told in-Pharmatechnologist.com it was working on a similar mechanism to prevent any API import-related drug shortages.
To date however, the HGA is the only organisation to provide a full overview of the process, which is a move that was welcomed by European Generic Medicines Association (EGA) senior manager of quality and regulatory affairs, Julie Marechal-Jamil.
She told in-Pharmatechnologist.com the EGA “welcomes the HMA publication answering an industry call for a coordinated and harmonised approach by EU MSs in the handling of critical situations where the active substances… arrive at the EEA from countries that are not included in the list referred to in article 111b and without the required written confirmation.
“EGA members will keep monitoring the situation closely and actively pursue the dialogue with national and EU authorities to secure through a pragmatic implementation, the continuity of generic medicines supply to patients in the EU and outside.”
Indian and China concerns
Marechal-Jamil went on to explain that generic drugmakers – like their branded drug producing counterparts – have developed API management strategies and contingency plans designed to prevent disruption of supply chains and shortages.
Non-branded drugmakers where also in close contact with European authorities ahead of the July 2 implementation date for the new import requirements, she added.
“The EGA acknowledges the support received from authorities, both at national and EU level, in dialogue with key API exporting countries, to ensure preparedness in time for the implementation of the new EU API importation rules.
But despite these efforts, the EGA still has questions about key API supply hubs according to Marechal-Jamil, who explained that: “There are still concerns with some important API exporting countries – for example India and China - where, in spite of all efforts, written confirmations are issued yet, to date, not covering the entirety of all APIs exported to the EU.”