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Jun 18, 2020

EMA Annual Report 2019 Published
On 15 June 2020 the EMA released its annual report highlighting the most significant achievements in 2019.

EMA released its annual report showcasing the Agency’s efforts to protect and promote human and animal health in Europe and highlights the most significant achievements in 2019.

For the first time, EMA’s annual report is available in digital form. The reader can navigate through the digital content and explore specific topics in depth, including interviews and short videos. The digital version also includes an interactive timeline of the Agency’s main activities in 2019.

The first part of the report draws attention to some of the Agency’s main initiatives and challenges, including the successful relocation to Amsterdam, the development and finalisation of the ‘regulatory science strategy to 2025’, the recommendations developed by EMA and national competent authorities on big data in medicines regulation and the response to the discovery of nitrosamine impurities in medicines.

The second part is dedicated to key figures, including core statistics that summarise the main outcomes of EMA’s regulatory procedures and activities, as well as trends and changes observed in recent years. More statistical information about EMA can be found in a print-ready version in pdf format that is published alongside the digital annual report.

Read the pdf 

Guidance on Remote GCP Inspections During the COVID-19 Pandemic
On 10 June 2020 the EMA announced that guidance is available for inspectors on how to initiate and conduct remote inspections to verify compliance with GCP standards during the COVID-19 pandemic.

The guidance covers all phases of remote GCP inspections, with a particular focus on the more challenging aspects, such inspection initiation, feasibility assessment and preparation.

Remote inspections should follow the applicable procedures that already exist for coordinating, preparing and conducting GCP inspections requested by the Committee for Medicinal Products for Human Use (CHMP), but should also take into consideration the limitations imposed by using a remote process and recognise that such a remote process cannot completely replace on-site GCP inspections.

The purpose of this document is to outline the requirements and specificities of remote GCP inspections identifying the points to be considered during the preparation, conduct, and reporting phase in this context.

Read the pdf 

The Electronic Common Technical Document (eCTD) v4.0 Q&A v1.3 reaches Step 4 of the ICH Process
On 8 June 2020 the ICH announced that ICH eCTD v4.0 Q&A v1.3 document reached Step 4.

The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.3 reached Step 4 of the ICH process in May 2020.

The eCTD v4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group (i.e. M8 IWG) on the eCTD v4.0 Implementation Package, and further to receiving new Change Requests in 2019, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.3.

Read more online 

Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency
On 8 June 2020 the FDA announced the availability of this guidance for industry.

FDA is issuing this guidance to address questions FDA has received asking for clarification regarding FDA’s enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency (PHE). PDMA is part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the relevant implementing regulations regarding drug samples are in 21 CFR part 203 (part 203), subpart D.

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Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 5 June 2020 the FDA announced the availability of this guidance for industry and FDA administration staff.

FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act (42 U.S.C. 247d(a)(2)).

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FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19
On 2 June 2020 the EMA and FDA published the joint document for medicine developers planning to submit an iPSP and PIP.

Given the global public health crisis resulting from the coronavirus disease 2019 (COVID-19) pandemic, FDA and EMA are providing procedural assistance to sponsors and applicants who anticipate submission of pediatric product development plans for new drugs and biological products for the treatment or prevention of COVID-19. FDA and EMA are issuing this Common Commentary to streamline administrative processes and facilitate efficient submission of an iPSP and PIP. This Common Commentary addresses only the submission of an iPSP and PIP for a drug or biological product for treatment or prevention of COVID-19.

Given the need to generate clinical trial data to inform safe and effective use of products to treat and prevent COVID-19 in pediatric patients, FDA and EMA encourage early submission of an iPSP and PIP. Furthermore, FDA and EMA meet as needed to exchange information to facilitate product development for the pediatric population.

Read the pdf 

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators
On 2 June 2020 the FDA announced the availability of this guidance for IRBs and clinical investigators.

During the COVID-19 public health emergency, the Agency has received a substantially increased volume of individual patient expanded access requests for COVID-19 investigational drugs. Although FDA has issued guidance on expanded access requests, including expanded access for individual patients, the Agency is aware that Institutional Review Boards (IRBs) seek clarity regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill its obligations under 21 CFR Part 56. Therefore, FDA is issuing this guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.

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Questions and Answers: Qualification of Digital Technology-based Methodologies to Support Approval of Medicinal Products
On 1 June 2020 the EMA updated the Q&A document on the successful qualification of digital technology-based methodologies intended to support approval of medicinal products.

The principal focus of the document is to support Qualification of methodologies based on digital technologies in the context of medicinal product development. It may also be of assistance to applicants in the preparation for other types of EMA procedures and interactions, such as Innovation Task Force (ITF) meetings, scientific advice briefing books drafting, and preparation of Marketing Authorisation Applications (MAAs).

This Q&A document is not intended to provide comprehensive guidance; instead, it reflects EMA's current experience at the time of publication. As this is an area of rapid evolution, further considerations may be added as EMA's experience increases.

Due consideration should be given to general guidance documents on Qualification available on the EMA website, which is supplemented by this Q&A document focusing on aspects specific to digital technologies.

Read the pdf 


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