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Editorial
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Authors: Dr C. Michaela Gottwald and Dr
Henriette Wolf-Klein
FORUM Institut für Management GmbH
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On 21 March and 29 May 2024, Online Pharma
FORUM hosted two significant sessions addressing the comprehensive
revision of EU pharmaceutical legislation and select legal issues in
drug regulation. These sessions provided valuable insights into the
implications for pharmacovigilance and the anticipated changes in
commercial protection periods.
... more
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News from ICH |
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The ICH M14 draft Guideline on “General
Principles on Plan, Design and Analysis of Pharmacoepidemiological
Studies That Utilize Real-World Data for Safety Assessment of
Medicines” has reached Step 2 of the ICH process on 21 May 2024.
Details
The ICH M12 Guideline "Drug Interaction Studies" and "Drug
Interaction Studies Questions and Answers" reached Step 4 of the ICH
Process on 21 May 2024.
Details
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News from EDQM |
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The EDQM has drafted a guideline
"Content of the dossier for sterile substances".
Details
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News from EMA |
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The PMS Product User Interface (PUI) was
launched on 31 May 2024, in read-only mode on Product Lifecycle
Management (PLM) Portal.
Details
On 14 May EMA published "Products Management Services -
Implementation of International Organization for Standardization
(ISO) standards for the identification of medicinal products (IDMP)
in Europe".
Details
New, product specific tiles for electronic product information (ePI)
and the Product Management Service (PMS) Product User Interface have
been included in addition to the web-based electronic Application
Forms on the PLM Portal′s landing page.
Details
From 4 June 2024, the following types of new pediatric
submissions must be carried out via IRIS: Initial pediatric
investigation plan (PIP); Modification of an agreed PIP;
Product-specific waiver; Compliance check; Annual report on
pediatric deferred measures; Confirmation of applicability of a
class waiver, or inclusion of an indication within a condition;
Discontinuation of pediatric development.
Details
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News from BfArM |
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With the relaunch of the PharmNet.Bund website on 28
May 2024, the information, training documents, FAQs and logins for
the PharmNet.Bund specialist applications were integrated into the
new portal.
Details
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News from Swissmedic |
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On 1 June 2024 Swissmedic has issued updated key
guidance covering variations, temporary authorisation, meetings for
applicants and time limits for authorisation.
Details
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Kind regards,
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Dr Rebekka Bitsch
Your contact for
Regulatory Affairs (Human)
+49 6221 500-565 |
Dr C. Michaela Gottwald
Your contact for
Regulatory Affairs (Veterinary)
+49 6221 500-610 |
Dr Birgit Wessels
Your contact for
CMC
+49 6221 500-652 |
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Verena Planitz
Your contact for
Global Regulatory Affairs
+49 6221 500-655
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