Regulatory Focus™ > News Articles > 2021 > 7 > Euro Roundup: EMA hails doubling of SME’s MAA success rate

Euro Roundup: EMA hails doubling of SME’s MAA success rate

Posted 01 July 2021 | By Nick Paul Taylor 

Euro Roundup: EMA hails doubling of SME’s MAA success rate

The European Medicines Agency (EMA) has hailed the doubling of the proportion of successful filings for marketing authorization from small and medium-sized enterprises (SMEs) from 2016 to 2020.
 
Last year, 89% of approval applications from SMEs ended in success, up from 40% in 2016. The new high for the success rate follows several years in which the figure has ticked upward, rising to 57% in 2018 and 67% in 2019. EMA offered no specific explanation for the rise but presented the data as part of a report documenting the support it provides to SMEs.
 
More than half of SMEs received scientific advice before filing, according to EMA. SMEs made up a significant minority of all the companies involved in Innovation Task Force briefing meetings and requests for parallel consultation with HTA bodies.
 
The EMA report reveals a potential consequence of Brexit. EMA tracked a rise in the number of SMEs registered in Ireland and the Netherlands as the UK left the European Union, suggesting some small companies may have relocated or set up offices in the countries to continue to reap the benefits of having a presence in the bloc.
 
EMA tracked a fall in the success rate of veterinary medicine applications from SMEs in 2020, but the small sample size makes the figure prone to fluctuations. The dataset for 2020 features two filings, one of which was withdrawn.
 
EMA Statement, SME Report
 
UK finds insufficient evidence to confirm safety of macrolide antibiotics in pregnancy
 
The UK Commission on Human Medicines (CHM) has ruled there is insufficient evidence to confirm if the macrolide antibiotics erythromycin, clarithromycin and azithromycin can cause birth defects and miscarriage when taken in early pregnancy.
 
CHM, a committee of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) that advises ministers, assessed the evidence on the use of macrolide antibiotics in pregnancy after the publication of a large cohort study that linked the products to increased risks of malformations relating to the heart or blood vessels in babies when taken in the first trimester. An earlier review found conflicting information in the summaries of product characteristics.
 
The CHM’s attempt to draw a firm conclusion about the safety of the antibiotics in early pregnancy was undermined by the low quality of evidence. CHM found most studies had a serious risk of bias. As such, CHM was not able to confirm or dismiss the findings of the cohort study.
 
CHM wants to see high-quality research into the effects of the three antibiotics during pregnancy. In the absence of such research, the committee is advising physicians to prescribe macrolide antibiotics when the potential benefits outweigh the risks and no suitable and safe alternative is available, such as in women with a true penicillin allergy.
 
MHRA Report
 
EMA updates clutch of chapters on the identification of medicinal products
 
EMA has revised its guidance on the implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP).
 
The updates affect a handful of documents, although some of the texts have only undergone small revisions. EMA adopted a major update to the chapter on the process for the electronic submission of medicinal products information. Version 2.0 of chapter 3 features more details of the different types of data submissions to Product Management Services.
 
EMA also updated chapter 8, which covers practical examples, to version 2.0. The updated chapter features new examples and updated full model examples. EMA revised an annex that covers two examples in depth in line with the changes to chapter 8.
 
The other two chapters revised by EMA underwent more minor revisions. EMA added new data elements and made minor general updates to its chapter on data elements for the electronic submission of information on medicinal products for human use. Similarly, the agency updated its introduction to the EU Implementation Guide with details relevant to version 2.1 of the documents.
 
Chapter 3, Chapter 8
 
EMA shares advice on co-packaged devices in update to MDR, IVDR guidance
 
EMA has updated its Medical Devices and In Vitro Diagnostic Regulations (MDR/IVDR) advice with details of co-packaged medicinal products. The answers address medicinal products that include a medical device in the secondary packaging.
 
In the update, EMA explains that co-packaged products need to be distinguished from drug-device combinations that form a single integral product. Devices included in co-packaged products must be in conformity with MDR. That requirement extends to the inclusion of information such as the unique device identifier.
 
Marketing authorization holders and applicants need to ensure devices co-packaged with their products meet the MDR safety and performance requirements, but do not need to file a variation to show compliance if they received approval before 26 May 2021. 
 
If a co-packaged device did not require assessment by a notified body under the old directive, but has been upclassified for MDR, the marketing authorization holder is eligible for the transition period that gives them until 26 May 2024 to comply with the new requirement.
 
EMA Q&A
 
ABPI adds reporting requirements on relationships with patients and journalists
 
The Association of the British Pharmaceutical Industry (ABPI) has published its 2021 Code of Practice for the pharmaceutical industry. Changes to the 2019 Code include the requirement for companies to disclose relationships with patient organizations and journalists.
 
Most of the clauses are copied over from the 2019 document. New requirements include the release of annual lists of patient organizations that provide contracted services or receive donations, grants or sponsorship, including in relation to events and meetings, from pharma companies. The Code requires the disclosure of the monetary value of the agreements and the nature of the support or services.
 
The 2021 Code also requires companies to annually publish details of contracts with members of the UK public, including patients and journalists, for speaking at meetings, helping with training, writing articles, participating in advisory boards, advising on the design of clinical trials and being part of market research. The data for 2022, the first mandatory year, must be disclosed by 30 June 2023.
 
ABPI Code
 
European Pharmacopoeia to eliminate rabbit pyrogen test within five years
 
The European Pharmacopoeia (Ph. Eur.) Commission has committed to try to completely replace the rabbit pyrogen test (RPT) within five years. Ph. Eur. will need to replace RPT with a suitable in-vitro alternative in 59 documents to achieve its goal.
 
An in-vitro alternative to RPT, the monocyte-activation test (MAT), has been part of Ph. Eur. since 2009. The addition of the test, which the European Directorate for the Quality of Medicines (EDQM) called “a significant step forward in terms of animal welfare,” provided an alternative to RPT that is capable of detecting both endotoxin and non-endotoxin pyrogens.
 
However, “Rabbits continue to be used extensively to detect pyrogenic substances,” according to EDQM. The directorate said use of RPT has persisted despite “multiple efforts” to encourage a switch to MAT.
 
The slow pace of change has persuaded Ph. Eur. to work to eliminate RPT from its texts. Changes to each of the 59 texts will require a public consultation. While Ph. Eur. works through the process of changing the texts, it is encouraging users to seek alternatives to RPT. EDQM said MAT is currently the best alternative.
 
EDQM Notice

 

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