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Online Pharma FORUM "Update Clinical
Trials Regulation"
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Author: Dr Henriette
Wolf-Klein, FORUM Institut für Management
GmbH
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On 8 December 2022, the Online
Pharma FORUM webcast took place with regard to the
Clinical Trials Regulation. PD Dr Thomas Sudhop was the
expert lecturer.
At the beginning of the webcast,
Dr Sudhop addressed the principles of submitting a
clinical trial application under the new Clinical Trials
Regulation (CTR), which has been active since 31 January
2022. Part 1 of the application consists of, among other
things, the protocol, IMPD, IP, label, GMP documents and
is the same for all Member States concerned (= MSC).
Part 2 covers national concerns of individual Member
States such as informed consent, insurance, data
protection, compensation, etc.
... more |
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| News
from the European Court |
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The General Court annuls the
Commission Delegated Regulation of 2019 in so far as it
concerns the harmonised classification and labelling of
titanium dioxide as a carcinogenic substance by
inhalation in certain powder forms.
Details
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| News
from the ICH |
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The ICH Guideline Q13 on continuous
manufacturing of drug substances and drug products
comes into effect on 10 July 2023.
Details
The
comments with regard to the ICH Harmonized Guideline
Drug Interactions M12 have been aggregated and
published.
Details
The
ICH M13A draft Guideline on Bioequivalence for
Immediate-Release Solid Oral Dosage Forms reached
Step 2 of the ICH process on 20 December 2022.
Details
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| News
from the EU Commission |
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The EU Commission published a Guideline "on the
format and content of applications for designation as
orphan medicinal products and on the transfer of
designations from one sponsor to another".
Details
The
EU Commission has published a manual "on borderline
and classification for medical devices under
Regulation 2017/745 on medical devices and Regulation
2017/746 on in vitro diagnostic medical devices".
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| News
from the EMA |
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The updated draft eCTD v4.0 implementation
timeline for EU is now available.
Details
The
updated PLM Portal eAF timeline now
available.
Details
The
EMA has launched the 2nd Issue of the
DADI-newsletter with updates on UAT, eAF, PMS and
more.
Details
EMA
released an IRIS guide for parallel distribution
applicants. The guide has been produced to help
individuals using the IRIS Regulatory & Scientific
Information Management platform understand how to use
the portal to submit a notification for parallel
distribution. The document is intended for Industry
users who have already been granted Industry user access
roles for the IRIS portal.
Details
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| News
from the CMDh |
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The CMDh has agreed updates of several CMDh guidance
documents to remove the requirement for MAHs to provide
a list of dispatch dates (dates of dispatch to the CMS)
with the RMS submission. With the mandatory use of CESP
for submissions, it was considered that the list of
dispatch dates is no longer needed. The review follows
an update of the CMDh BPG for the handling of Type II
Variations in MRP (Chapter 5) in October, where this
change was first agreed.
Details
Stay
up to date with your variation submission with our
online seminar "Qualitätsbedingte Variations" (in
german) on 6 and 7 February 2023.
Details
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| News
from the HMA |
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The HMA Core Group for medical devices has published
a statement on effective application of the EU
regulatory system for medical devices.
Details
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| News
from the BfArM and the PEI |
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BfArM and PEI have published a joint recommendation
on the Notification of Observational Studies
according to § 67 paragraph 6 of the German Medicines
Act and on the notification of non-interventional safety
studies in accordance with § 63f German Medicines Act.
Details
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| Veterinary
news |
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It is possible to comment on the concept paper "on a
guideline on risk management requirements for
elemental impurities in veterinary medicinal
products" until 31 March 2023.
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Kind regards,
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Dr Tatjana
Mende
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
Quality, Safety, CMC
+49 6221
500-652 |
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