Country	Organization	Document	Status	Category
International	ICH	ICH S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals - Questions and Answers	Final	Safety
Australia	TGA	Which clinical trials scheme should I choose?	Final	Clinical Trials
Australia	TGA	Management and communication of medicines shortages - proposed implementation approach	Draft	Supply
Australia	TGA	Management and communication of medicine shortages in Australia - A new protocol	Draft	Supply
Australia	TGA	GMP clearance process improvements: Common issues when completing the online application form in TGA Business Services	Final	GMP/Application Process
Australia	TGA	Biologicals regulatory framework proposed changes to start on 1 July 2018, including changes to regulation of autologous human cell and tissue products and classification of biologicals	Final	Application Process/Product Classification
Australia	TGA	Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS	Draft	Safety
Australia	TGA	Reformatting Product Information: Frequently asked questions	Final	Product Information
Canada	HC	ICH S3A Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling	Final	ICH – Safety
Canada	HC	Notice: ICH M7(R1): Genotoxic Impurities - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk	Final	ICH – Safety
Canada	HC	ICH E18: Genomic Sampling and Management of Genomic Data	Final	ICH – Efficacy
Canada	HC	Classification of Dental Plaque-Disclosing Products as Drugs	Final	Classification/Application Process
Canada	HC	Proposed Pathogens of Interest List	Draft	R&D
Canada	HC	ICH E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population	Final	ICH - Efficacy/Clinical Trials
Canada	HC	ICH Q11: Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances	Final	ICH - Quality
Canada	HC	ICH Q3C(R6): Impurities: Guidelines for Residual Solvents	Final	ICH - Quality
EU	OCABR	Revised human vaccines guidelines with aP components	Final	Vaccines
EU	EDQM	Validation of computerised systems core document (PA/PH/OMCL (08) 69 R7)	Final	QSE
EU	EDQM	Validation of Computerised Systems Annex 1 – Validation of Excel Spreadsheets (PA/PH/OMCL (08) 87 R6)	Final	QSE
EU	EDQM	Validation of Computerised Systems Annex 2 – Validation of Complex Computerised Systems (PA/PH/OMCL (08) 88 R5)	Final	QSE
EU	CMDh	Template for Summary Public Assessment Report -Generics (CMDh/305/2013)	Final	Procedural
EU	EMA	Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)(EMA/CHMP/CVMP/SWP/246844/2018)	Final	Safety
EU	EMA	BWP Ad-hoc Influenza Working Group: Amended EU recommendations for the seasonal influenza vaccine composition for the season 2018/2019 (EMA/CHMP/BWP/209019/2018)	Final	Vaccines
EU	EMA	Draft guideline on clinical evaluation of vaccines (EMEA/CHMP/VWP/164653/05 Rev. 1)	Draft	Vaccines
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev.55 (Correction)): Summary of Changes	Final	Pharmacovigilance/Safety
EU	EMA	Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of a development medicinal product (EMA/525101/2014)	Final	Pharmacovigilance
EU	EMA	Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Update of an authorised medicinal product (EMA/543104/2014)	Final	Pharmacovigilance
EU	EMA	Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of an organisation (EMA/467742/2014)	Final	Pharmacovigilance
EU	EMA	Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of a pharmacovigilance system master file location (EMA/524417/2014)	Final	Pharmacovigilance
EU	EMA	Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of an authorised medicinal product (EMA/469926/2014)	Final	Pharmacovigilance
EU	EMA	Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Maintenance operations - Invalidation of an authorised medicinal product (AMP) entity in the XEVMPD (EMA/197297/2018)	Final	Pharmacovigilance
EU	EMA	Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Maintenance operations - Update of a marketing authorisation holder (MAH) organisation entity in the XEVMPD (EMA/177298/2018)	Final	Pharmacovigilance
EU	EMA	EudraVigilance release notes v.1.13 (EMA/253902/2018)	Final	Pharmacovigilance
EU	EMA	Criteria for classification of critical medicinal products for human and veterinary use: Shortages due to GMP non-compliance/quality defects (EMA/24304/2016)	Final	GMP
EU	EMA	Points to consider for the overall assessment of a supply shortage of a medicinal product for human and veterinary use due to GMP Non-compliance/quality defects (EMA/352178/2013)	Final	GMP
EU	EMA	Qualification opinion on Proactive in COPD (EMA/CHMP/SAWP/226829/2018)	Final	Clinical Trials
EU	EMA	Cover note on XEVMPD substance controlled vocabulary following the quality control exercise (EMA/93253/2014, Rev. 1)	Final	Pharmacovigilance
EU	EMA	Redistribution of the UK centrally authorised product portfolio - European Medicines Agency working groups on committees’ operational preparedness (EMA/17176/2018)	Final	Procedural
EU	EMA	Data quality control methodology for data submitted under Article 57(2) of Regulation (EC) No.726/2004 (EMA/227883/2014, Rev. 2)	Final	Procedural
EU	EMA	EMA Substance names best practice: Procedure and principles to handle substance name in the substance management system (EMA/40951/2014, Rev. 1)	Final	Procedural
EU	EMA	Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of approved substance information (EMA/254278/2014, Rev. 2)	Final	Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (EMA/136148/2012, Rev.51)	Final	Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (EMA/136157/2012, Rev.21)	Final	Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (EMA/136146/2012, Rev.16)	Final	Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (EMA/136156/2012, Rev.51)	Final	Pharmacovigilance
EU	EMA	Public Hearing - Guidance for participants	Final	Procedural
EU	EMA	Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version (EMA/CHMP/187859/2017)	Draft	Clinical Trials/Pediatrics
EU	EMA	List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders (EMA/701527/2017 Corr 5)	Final	Pharmacovigilance
EU	EMA	List of signals discussed at the PRAC since September 2012 (EMA/PRAC/530804/2013)	Final	Pharmacovigilance
EU	EMA	Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement (EMA/189939/2018)	Draft	GMP
Hong Kong	PBB	Continuing Professional Development for Authorized Persons	Final	Procedural
Iceland	IMA	Z-classification revoked for S-classified medicinal products which are foreseen to maintain their S-classified status	Final	Labeling
Latvia	SAMLV	Amendments to the Procedure for Registration of Medicinal Products	Final	Application Process
New Zealand	Medsafe	Proposed Changes to fees payable under the Medicines Regulations 1984	Draft	Application Process
Philippines	FDA Philippines	Period of Payment of E-Portal Applications	Final	Procedural
Saudi Arabia	SFDA	Transparency and Payments Disclosure Guidance for Medical Companies	Final	Advertising/Promotion
Saudi Arabia	SFDA	Integration Guide for Drug Track and Trace System	Draft	Traceability/Supply
Saudi Arabia	SFDA	Drug Barcoding Specifications	Final	Traceability/Supply
Saudi Arabia	SFDA	The GCC Guidelines for Stability Testing	Final	QSE
Singapore	HSA	Guidance on T herapeutic Product Registration in Singapore - 2018 (TPB-GN-005-001)	Final	Application Process
Singapore	HSA	Application Checklist for NDA and GDA (ICH CTD)	Final	Application Process
Singapore	HSA	Application Checklist for MAV (ICH CTD)	Final	Variations
Singapore	HSA	Application Checklist for NDA and GDA (Asean CTD)	Final	Application Process
Singapore	HSA	Application Checklist for MAV (Asean CTD)	Final	Variations
Singapore	HSA	Target Processing Timelines	Final	Procedural
Singapore	HSA	Guideline on the Registration of Human Plasma-derived Therapeutic Products	Final	Application Process
Singapore	HSA	Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications	Final	Bioequivalence/QSE
Singapore	HSA	Guidance on Drug Master Files	Final	Application Process/Safety
Singapore	HSA	Drug Master File Submission Form Template	Final	Application Process
Singapore	HSA	Guideline on PRISM Submission	Final	Application Process
Singapore	HSA	Confirmation of Quality dossiers with Reference Agency's Approval	Final	Application Process
Singapore	HSA	Dossier Clarification Supplement	Final	Application Process
Tanzania	TFDA	Submission of information (notification) on medical gases circulating on Tanzanian market	Final	Procedural
UK	HRA	GDPR guidance for researchers and study coordinators	Final	Data Protection/Clinical Trials
UK	MHRA	Good laboratory practice (GLP) for safety tests on chemicals	Final	QSE
UK	MHRA	Valproate use by women and girls	Final	Safety/Pharmacovigilance
UK	MHRA	Decide if your product is a medicine or a medical device	Final	Application Process/Product Classification
UK	MHRA	Advertise your medicines	Final	Promotion/Advertising
UK	MHRA	Educational materials and associated distribution plans	Final	Pharmacovigilance
US	FDA	Clinical Trial Imaging Endpoint Process Standards: Guidance for Industry	Final	Clinical/Medical
US	FDA	Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals - Guidance for Industry	Draft	Pharmacology/Toxicology
US	FDA	Opioid Dependence: Developing Depot Buprenorphine Products for Treatment	Draft	Clinical/Medical
US	FDA	Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers: Guidance for Industry	Final	ICH – Quality
US	FDA	Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products -Quality Considerations	Draft	Pharmaceutical Quality/CMC
US	FDA	Special Protocol Assessment Guidance for Industry	Final	Procedural
US	FDA	Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination: Guidance for Industry	Draft	Procedural
US	FDA	E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population	Final	ICH – Efficacy
US	FDA	Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials	Draft	Clinical/Medical/Clinical Trials
US	FDA	Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs	Draft	Clinical/Medical
US	FDA	Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation	Final	Pharmaceutical Quality/CMC
US	FDA	Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry - Technical Specifications Document	Final	Vaccines
US	FDA	Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria: Draft Guidance for Industry and Food and Drug Administration	Draft	Application Process/Procedural

Global Pharma Guidance Tracker – April 2018

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