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EMA Nitrosamines Q&A Rev 12 (10 OCT 2022) - Temporary AI limit
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6
|
1202
|
October 20, 2022
|
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WHO Revision on Rafampicin Monograph and Test Method
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0
|
290
|
October 19, 2022
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Nitrosamine Impurities: Extension of the Deadline for the Submission of Variations
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9
|
748
|
September 28, 2022
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Swissmedic updates DMF submission form to include Nitrosamine Exchange information
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1
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402
|
September 25, 2022
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The deadline for step2 in EMA is coming
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2
|
378
|
September 23, 2022
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Nitrosamines in Pharmaceuticals: Toxicity, Risk Analysis, Chemistry and Test Methods
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0
|
518
|
September 22, 2022
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Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF
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4
|
435
|
September 6, 2022
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Health Canada Nitrosamine Guidance -Effective Sep 2022
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0
|
821
|
September 5, 2022
|
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What Goes Wrong When API Quality is Compromised?
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1
|
302
|
August 13, 2022
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Step 2: No Nitrosamine detected response template (updated)
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0
|
241
|
August 12, 2022
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Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities
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0
|
328
|
August 7, 2022
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CMDh practical guidance for Marketing Authorisation Holders
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0
|
422
|
August 3, 2022
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EMA/CHMP Concept paper on the revision of the guideline on the chemistry of active substances
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1
|
368
|
July 30, 2022
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Egyptian Drug Authority (EDA) Technical Consultation
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1
|
284
|
July 28, 2022
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SwissMedic - Applicant's consent to share Nitrosamine information
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0
|
252
|
July 5, 2022
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Third Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
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2
|
412
|
July 1, 2022
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South African Health Products Regulatory Authority (Nitrosamines)
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1
|
455
|
June 28, 2022
|
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Guidance on Nitrosamine Impurities from Health Canada
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6
|
379
|
June 3, 2022
|
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Sept 2021 Revised QnA document from EMA
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7
|
631
|
June 2, 2022
|
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UPDATED - Health Canada - Q&A Document on Nitrosamine
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1
|
582
|
June 1, 2022
|
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ANVISA Ver 2- Guide for Controlling Nitrosamines in Active Pharmaceutical Ingredients and Medicines
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1
|
1196
|
May 11, 2022
|
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Taiwan FDA 2020 Annual Report -Nitrosamine activities
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0
|
300
|
April 26, 2022
|
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Draft of Addendum to ICH M7(R2) available for comments
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3
|
281
|
April 26, 2022
|
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EMA's updated Q&A on nitrosamines - March 2022
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3
|
721
|
April 4, 2022
|
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EFPIA Workflows risk management of nitrosamine in medicines -Translations
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1
|
687
|
March 10, 2022
|
|
ANVISA's guide document on Nitrosamine NEW!
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6
|
1319
|
March 10, 2022
|
|
Mutagenic Impurities Strategies for Identification and Control - now published
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9
|
415
|
March 2, 2022
|
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Proofing risk assessment: preventing the next nitrosamine
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0
|
249
|
February 2, 2022
|
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ANVISA Final guidance presentation -Tomorrow 02/Feb/22
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2
|
385
|
February 2, 2022
|
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ANVISA's guidance english version
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5
|
691
|
January 20, 2022
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