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EMA Guidance: Scientific Advice and Protocol Assistance

WEBEuropean Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also the CHMP protocol …

Actived: 7 days ago

URL: https://www.regulatoryaffairsnews.com/post/ema-guidance-scientific-advice-and-protocol-assistance

Health Canada: Guidance Document Management of Drug …

WEBHealth Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA).This guidance …

Category: Health Go Health

Health Canada: Guidance on Validation rules for Regulatory …

WEBRegulatory transactions are validated by Health Canada before they are released to sponsors, and if the validation fails due to one or more errors detected, a …

Category: Health Go Health

Health Canada: Guidance on Master Files Procedures

WEBHealth Canada recently (26 June, 2023) published an updated guidance on "Guidance on Procedures and Administrative Requirements for Master Files".A key …

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EMA Guideline: Computerised Systems & Electronic Data in …

WEBRecently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials" that replaces …

Category: Medicine Go Health

South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems

WEBEarlier today (06 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline on "Pharmacovigilance Systems".A …

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South Africa: Information Guideline and Quality and …

WEBRecently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information Guideline" and "Quality and Bioequivalence …

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Guidance on Developing Drug Shortage Management Plans

WEBThe French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage management plans for …

Category: Medicine Go Health

Philippines FDA: Guidelines on the Application for License to …

WEBYesterday (6 June 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines on the Application for License to Operate of Health …

Category: Food Go Health

Singapore's HSA: Consultation on eCTD Implementation & Risk

WEBOn 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions for therapeutic products held from 2 …

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Health Canada Guidance: Preparation of Regulatory Activities in …

WEBHealth Canada recently (09 June, 2023) published an updated guidance on "Preparation of Regulatory Activities in Non-eCTD Format" that describes the filing …

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UK MHRA Guidance: Apply for a Licence to Market a Medicine in …

WEBLast Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a Licence to Market a …

Category: Medicine Go Health

GCC Guidance on Labeling Information, SPC and PIL

WEBThe Gulf Health Council released a new updated version of the guidance on 12th August 2021 on “Guidance for Presenting the Labeling Information, SPC and …

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South Africa’s (SAHPRA’s) updated Reliance Guideline for a New

WEBThis guideline is intended to provide information and guidance to applicants/HCRs on the prescribed requirements and process to be followed, in cases …

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Health Canada Recommendations: ICH Q3D(R2) Guideline for …

WEBYesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized Guideline for Elemental …

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Philippines FDA: Guidelines on the Licensing of Retailers of …

WEBOn 8 May 2020, the Philippines Department of Health (DOH) entitled “Revised Guidelines on the Unified Licensing Requirements and Procedures” was …

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Canada Guidance: Regulatory Enrolment Process (REP)

WEBYesterday (29-September 2022) Health Canada updated their guidance on Regulatory Enrolment Process (REP).Health Canada's Regulatory Enrolment Process (REP) …

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Malaysia NPRA: Guidance on Drug Registration

WEBMalaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (26 July, 2023) released an updated guidance on "Drug Registration" which details the …

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