Special dispensation: streamlined rules in the context of COVID-19
SummaryThe continuing pandemic has disrupted everything in life sciences, including European regulatory activity. So simplified and more flexible authorisation procedures are proving very welcome in keeping supply chains moving. Monia Nica, Senior Regulatory Affairs Manager at Arriello, summarises the temporary changes to requirements.
- Author Company: Arriello
- Author Name: Monia Nica
The continuing pandemic has disrupted everything in life sciences, including European regulatory activity. So simplified and more flexible authorisation procedures are proving very welcome in keeping supply chains moving. Monia Nica, Senior Regulatory Affairs Manager at Arriello, summarises the temporary changes to requirements.
Agencies across Europe have joined forces to determine how best to maintain medicines availability as the pandemic continues to wreak havoc on international supply chains. The result is a new set of guidelines for the exceptional circumstances from the European Commission (EC), in collaboration with the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), and the European Medicines Agency (EMA):
1. Faster approvals for COVID-related products.
A ‘zero-day’ mutual recognition/repeat use procedure means applications for access to new/additional markets won’t be delayed by the usual rounds of administrative preparations. If a drug is seen to help COVID-19 patients, it can be authorised and rolled out to other EU member states at an accelerated pace. Similar provisions have been made for helpful drugs identified in regions beyond the EU, to expedite their availability in Europe.
2. Revised renewals & sunset clause requirements.
Renewals’ dossier deadlines have been relaxed where a request is justified. New flexibility has been extended around sunset clauses, too. Ordinarily these dictate that the marketing authorisation of a medicine ceases to be valid if the medicine is not placed on the market within three years of the authorisation being granted, or if it is removed from the market for three consecutive years. But currently extensions can be requested without further justification if this is due to the pandemic.
3. Accelerated change management in the supply chain for critical COVID-19 medicines.
A new exceptional change management process (ECMP), applicable to critical COVID-19 medicines, allows for the swift implementation of changes in the manufacturing process or supply chain, to mitigate potential supply shortages. If an MAH needs to call upon active substances from suppliers that are not registered in the original dossier, for example, the procedure for logging that variation is now much simpler. Although as part of the commitment to safety and quality MAHs still need to notify the authorities about any changes within two days of implementation, they now have up to six months to submit the formal variation documentation.
4. Amendments to GMP/GDP certification & inspections.
Where Good Manufacturing and Distribution Practice (GMP/GDP) certificates would have expired during the global pandemic lockdown, authorities in Europe have extended current certificates until the end of 2021 without the need for any remedial action. This applies both to manufacturers and to importers of active substances and of finished medicinal products. Inspections, which cannot be conducted on site currently, may still be carried out through other channels – for instance, remotely.
5. Greater labelling flexibility.
To prevent updated labelling becoming a barrier to continuous product supply, requirements have been relaxed. For example, during the pandemic information may not have to be translated into the relevant official language if there are severe problems of availability of that medicinal product in a given EU member state.
Guidance around pharmacovigilance (PV) inspections was added in July 2020. If on-site inspections of companies’ PV practices are not currently possible, evaluations could be conducted using alternative channels including conference calls and online document sharing. Where remote inspections and system audits are permitted, it is important that these continue. Submitting individual case safety reports (ICSRs) in a timely fashion and updating labelling continues to be a critical activity, however.
7. Actions by Qualified Persons.
New leeway here concerns how checks by responsible persons are carried out. This includes auditing active substance manufacturers and certifying their products for batch release, which can now be done remotely. Where on-site audits of contract acceptors are not possible, the Qualified Person can fall back on paper-based audits and take into account the results of inspections or audits performed by EEA authorities. Remote audits should provide confidence that the contracted party is fit for purpose and will not negatively affect the wholesale distribution process.
Although the agencies have published details of all the latest guidelines, including Frequently-Asked Questions which they continue to update, there will always be situations that are not addressed directly by the published advice. To keep abreast of the latest developments, MAHs should check the agency web sites periodically, or consult an external regulatory advisor.
About the author
Monia Nica is Senior Regulatory Affairs Manager at Arriello, a global provider of innovative, high-impact market access, regulatory affairs & pharmacovigilance solutions and services for pharma and biotech firms primarily in Europe and North America.