Two months after being designated as the third Notified Body (NB) under the Medical Devices Regulation (MDR), Dekra Certification GmbH was annouced last week by the European Commission (EC) as the first NB to be designated under the EU In Vitro Diagnostic Regulation (IVDR).
With the entry into force of the new Medical Devices Regulation (2017/745/EU, “MDR”), many new requirements to be met by the manufacturers have been established.
As published in the Electronic submissions for CEP applications Revised Roadmap 2016-2020, from January 2020, EDQM will require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions and for submissions for substances for veterinary use only).
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In September 2019, Health Canada announced that 1st January 2020 is the new deadline for all new Master Files as well as all additional information and subsequent regulatory transactions will be mandatory in eCTD format.
The new Medical Devices Regulation (2017/745/EU, “MDR”) brings EU legislation in pace with technical advances, innovations in medical science, and progress in law making.
September is the World Alzheimer’s Month and this year Asphalion wants to talk about it because research suggests that leading a healthy lifestyle may help to reduce a person’s risk of developing dementia later in life.
Asphalion believes in helping employees find a little balance in their workday and we have measures to help reconcile work with private and family life.
Today, our experts Núria Romero, Sonia López, Nuria Cabello and Bernat Autonell participated in the workshop “Digital transformation and pharmacovigilance: technology update” organized by Arithmos, Asphalion and Oracle Health Sciences.
A draft NICE guidance recommends Voretigene Neparvovec (also called Luxturna) to treat people with vision loss caused by inherited retinal dystrophy from confirmed RPE65 gene mutations who have enough viable retinal cells.
The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records.
The FDA and the EMA are aligned in more than 90% of marketing authorizations (MA) for new drugs, according to a new study from EMA and FDA officials comparing 107 new medicine applications at the two agencies between 2014 and 2016.
We will be open in August and available to attend all your needs and requests as usual. Everyone here at Asphalion wishes you a wonderful and relaxing holiday season!
Last week, Aspahlion decided to collaborate with Aspen Pharmacare Spain in their campaign to help the the Fundació Banc dels Aliments de Barcelona in its food collection campaign “El Hambre No Hace Vacaciones”.
Asphalion’s LinkedIn community now has 10,000 followers! Today, we are celebrating reaching this milestone by having a special breakfast with all of Asphalion’s employees.
From 1st September 2019, all new Master Files submitted to Health-Canada must be in eCTD format, in addition, when converting MFs from non-eCTD format to the eCTD format, the entire MF must be provided in the first eCTD transaction, as a baseline requirement.
Last week, the Spanish Agency of Medicines and Medical Products (AEMPS) announced it’s notified body (NB) 0318 has begun the process to become designated as NB under the European Union’s medical device regulation (MDR).
On 6th June 2019 COCIR, the European trade association representing the medical imaging, radiotherapy, health ICT and electromedical industries, has published a document summarizing the current status in MDR implementation, which still shows little progress in a number of critical aspects.
In Asphalion, we have always been focused on helping to create a healthy, supportive, and safe work environment. That’s why we promote health and wellness programs to help and encourage our workers to develop healthy lifestyle practices.
A new version of the MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES has recently been published by the EU Commission (version 1.22, 05-2019).