Euro Roundup: EDQM advises on COVID viral vectored vaccines

The European Directorate for the Quality of Medicines (EDQM) has published advice on developing COVID-19 vaccines using viral vector platforms. The text covers analytical strategies for recombinant viral vectored vaccines such as AstraZeneca’s AZD1222 and Johnson & Johnson’s JNJ-78436735 (also known as Ad26.COV2.S).
 
Viral vectored vaccines are a relatively unproven and untested modality. Yet, the need to act quickly in response to the coronavirus outbreak means viral vectored vaccines are among the most advanced COVID-19 prophylactics. The prospect of an emerging modality being used in hundreds of millions of people has created a need for guidance on ensuring safety, performance and quality.
 
EDQM has responded with a document detailing the tests manufacturers can perform at each step of the production process. For example, EDQM suggests testing to confirm the absence of viruses that can replicate when producing replication-deficient vaccines. EDQM proposes running different tests at the seed lot, propagation, harvest, final bulk and final lot stages.
 
The document is not binding and EDQM is seeking feedback; such feedback may be incorporated into future updates.
 
EDQM Guidance, Press Release
 
Swissmedic clarifies temporary, fast-track pathways
 
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on temporary and fast-track authorizations to clarify the differences between the pathways and criteria for using them.
 
Swissmedic created the temporary authorization pathway to enable patients with life-threatening diseases to access new medicines even if the clinical documentation is insufficient to support a filing under the normal procedure. The fast-track pathway, in contrast, is for drug developers that have the documentation to file under the normal procedure but want to accelerate the regulatory review.
 
Those differences are articulated in guidance on the two pathways but Swissmedic identified a need for greater transparency regarding the eligibility criteria. By updating the guidance documents, the Swiss regulator hopes to make it easier for companies to choose the right procedure.
 
The updated documents include a decision tree and criteria for distinguishing between the pathways. The decision tree poses a series of questions, starting with “will the clinical data be final on receipt of the authorization application?” Companies that answer no to that question need to file temporary authorization applications.
 
As the decision tree shows, companies with final clinical data can apply for fast-track authorization. If Swissmedic rejects the request to board the fast track, a company can request a procedure with prior notification to shorten the time limit by 20%. Companies that receive Swissmedic rejections to both requests must follow the standard procedure.
 
Swissmedic added the decision tree in conjunction with an explainer on requirements related to the “point estimate in respect of efficacy and safety and its variation.” The section explains companies are expected to have statistically verified effects by the time they file for fast-track approval. As trials can be ongoing at the time of a filing for temporary approval, the statistical requirements for that pathway are different.
 
Swissmedic Notice
 
Swissmedic changes position on naming of biologic combination therapies
 
Sponsors must list the active substances, not trade names, in product information texts for combinations of biological therapies in Switzerland.
 
When Swissmedic implemented guidance on the naming of combinations last year, it required product information texts to detail the active substance names of synthetic medicines used in combinations, but brand names of biologics.
 
The decision was based on the “limited experience” with “medicinal products manufactured using biotechnological/biological processes and their biosimilars,” according to the agency. Since then, Swissmedic has become convinced the active substance names of biologics can be used without causing safety or efficacy concerns.
 
The change brings Swiss practices in line with practices in the US and European Union. “This harmonization of practice is crucial, since Swissmedic is extending its international collaboration with partner authorities for the review of authorisation applications,” Swissmedic wrote.
 
Marketing authorization holders (MAHs) affected by the change must modify their texts by 31 October, 2021 and tell Swissmedic when they have implemented the revisions.
 
Swissmedic Notice
 
Denmark’s DKMA announces whistleblowing scheme
 
People who work for and collaborate with the Danish Medicines Agency (DKMA) can use its whistleblower scheme to share details of serious incidents related to the agency’s execution of its duties.
 
DKMA identified criminal offences, gross or repeated violations of the law, administrative principles or essential internal guidelines, severe interpersonal conflicts at work and deliberate deception of members of the public and collaboration partners as incidents that qualify as serious enough to be covered by the whistleblower program.
 
DKMA employees, including volunteers, with information about such incidents can use the scheme. The scheme is also open to former employees, provided the incident took place during their time at DKMA, and potential employees who want to disclose information they obtained in connection with the recruitment process or contractual negotiations. Collaboration partners and their employees can use the scheme if they have a formal, continuous relationship with DKMA.
 
An online form is available for potential whistleblowers. The director general will decide how to respond to reports, unless they are the focus of the report. In that situation, the executive management in the Department of the Ministry of Health will handle the case.  
 
DKMA Notice
 
EMA: File type I variations by end of November
 
EMA has asked companies to submit type IA and type IAIN variations for 2020 by the end of the month. The deadline is intended to ensure EMA has time to acknowledge the validity of the flings by the time it closes for Christmas on 24 December.
 
European regulations require EMA to acknowledge the validity of variation submissions within 30 days. The closure of EMA over Christmas and New Year complicates that requirement, leading EMA to ask companies to submit type IA and type IAIN variations by the end of November to ensure they are processed this year.
 
EMA said MAHs that report Brexit-related type IA or type IAIN variations in December will receive acknowledgement of the validity of their submissions within 30 days. MAHs that want to report type IB variations have until 4 December to submit if the procedure is to start this year. Filings received from 7 December will start in the new year.
 
EMA Notice
 
MHRA shares guidance on conformity marking after Brexit
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the new UKNI marking.
 
Starting in January, goods that undergo mandatory third-party conformity assessments such as medical devices will need to use UKNI marking to be placed on the Northern Ireland market. The requirement reflects the fact Northern Ireland will continue to be subject to European Union rules after Brexit. The new guidance explains when and how to use UKNI marking. 
 
MHRA shared the guidance alongside a clarification that the grace period for registering devices does not apply to Class I devices, custom-made devices and general IVDs that are already registered with the agency.
 
MHRA Guidance, More