Country	Organization	Document	Status	Category
Australia	TGA	Testimonials and endorsements in advertising: Guidance on applying the Therapeutic Goods Advertising Code 2021 (Version 1.0)	Final	Advertising, Promotion
Australia	TGA	Notice of final decision to amend (or not amend) the current Poisons Standard in relation to isothiazolinones, methylisothiazolinone and methylchloroisothiazolinone	Final	Safety, Compliance, Product Classification
Australia	TGA	Notice of final decisions to amend (or not amend) the current Poisons Standard - ACMS #36, Joint ACMS-ACCS #29, ACCS #32	Final	Safety, Compliance, Product Classification
Belgium	CT-College	Advice for Belgian Ethics Committees regarding the assessment of safety reports in CTR applications	Final	Clinical Trials
Belgium	FAMHP	Coronavirus: the Belgian guideline for the management of clinical trials during the coronavirus pandemic no longer applies	Final	Clinical Trials
Belgium	FAMHP	Request to marketing authorisation holders to send the approved version of the risk management plan	Final	Procedural, Safety, Pharmacovigilance
Canada	HC	Guidance to market authorization holders on issuing health product risk communications	Final	Safety, Pharmacovigilance
Canada	HC	Validation rules for regulatory transactions provided to Health Canada in the non-eCTD format	Final	Procedural, Application Process
Canada	HC	Validation rules for regulatory transactions provided to Health Canada in the electronic Common Technical Document (eCTD) format	Final	Procedural, Application Process
Canada	HC	Considerations regarding the proposed use of psilocybin mushrooms in clinical trials, or as a drug accessed through the Special Access Program (SAP)	Final	Clinical Trials
Canada	HC	Notice: New products for serious adverse drug reaction hospital reporting	Final	Safety, Pharmacovigilance
Czech Republic	SÚKL	Requirements Governing the Text of Patient Information Leaflet Trial Subject Information Sheet/Informed Consent Form (KLH-22), Version 5	Final	Clinical Trials
Czech Republic	SÚKL	Scientific Advice on Marketing Authorisation Issues	Final	Application Process, Procedural
Czech Republic	SÚKL	Application for Scientific Advice (Consultation) provided by Marketing Authorisation Section of SÚKL	Final	Application Process, Procedural
Denmark	DMA	Guidelines for submission and technical validation of applications	Final	Application Process, Procedural
Denmark	DMA	Inspection of clinical trials (GCP inspection)	Final	Clinical Trials, Inspections
Denmark	DMA	Questions and answers on the Clinical Trials Regulation	Final	Clinical Trials
Denmark	DMA	Q&A about package leaflets and labelling	Final	Labeling, Packaging
EU	EC	Complex clinical trials – Questions and answers	Final	Clinical Trials
EU	EC	Clinical Trials Regulation (EU) No 536/2014: Questions & Answers (Version 6.1)	Final	Clinical Trials
EU	MDCG/CTEG	Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) (MDCG 2022-10)	Final	Clinical Trials, Companion Diagnostics
EU	CMDh	Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (CMDh/373/2018, Rev.11) [Track version]	Final	Procedural, Compliance
EU	CMDh	Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP (CMDh/426/2020, Rev. 2) [Track version]	Final	Procedural, Application Process, Administrative
EU	CMDh	Template: Decentralised Procedure - RMS Day 70 Preliminary Assessment report (CMDh/200/2007 Rev.10)	Final	Procedural, Application Process
EU	CMDh	Template (with instructions): Decentralised Procedure - RMS Day 70 Preliminary Assessment report/RMS Day 120 Draft Assessment Report (CMDh/440/2022)	Final	Procedural, Application Process
EU	CMDh	CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (CMDh/412/2019, Rev.16) [Track version]	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	CMDh	Template for nitrosamine risk evaluation in marketing authorisation applications (CMDh/439/2022)	Final	Procedural, Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	CMDh	Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (EMA/409815/2020 Rev.9)	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	CMDh	Examples for acceptable and not acceptable groupings for MRP/DCP products (CMDh/173/2010/Rev.21) [Track version]	Final	Procedural, Variations
EU	CMDh	Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 (CMDh/132/2009, Rev.58) [Track version]	Final	Procedural, Variations
EU	EMA	Article 57 User Interface (UI) Installation Guide (EMA/550318/2021, Rev. 1)	Final	Procedural, Administrative
EU	EMA	eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) user manual (EMA/308954/2012) Version 5.7	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Annex I to Procedure for Conducting GCP Inspections Requested by the CHMP: Investigator Site (EMA/INS/GCP/143492/2022)	Final	Clinical Trials, Inspections
EU	EMA	Annex II to Procedure for Conducting GCP Inspections Requested by the CHMP: Clinical Laboratories (EMA/INS/GCP/154768/2022)	Final	Clinical Trials, Inspections
EU	EMA	Annex IV to Procedure for Conducting GCP Inspections Requested by the CHMP: Sponsor and CRO (EMA/INS/GCP/155794/2022)	Final	Clinical Trials, Inspections
EU	EMA	Annex VI to Procedure for Conducting GCP Inspections Requested by the CHMP: Record Keeping and Archiving of Documents (EMA/INS/GCP/183077/2022)	Final	Clinical Trials, Inspections
EU	EMA	Annex VII to Procedure for Conducting GCP Inspections Requested by the CHMP: Bioanalytical Part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials (EMA/INS/GCP/188326/2022)	Final	Clinical Trials, Generics, Inspections
EU	EMA	Quick guide – Part I - How to evaluate a Clinical Trial Application: Assessment and Decision - CTIS Training Programme: Module 08 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	Quick guide – Part II - How to evaluate a Clinical Trial Application: Assessment and Decision - CTIS Training Programme: Module 08 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	Quick guide – Introduction - How to evaluate a Clinical Trial Application: Assessment and Decision - CTIS Training Programme: Module 08 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	Quick guide – Decision - How to evaluate a Clinical Trial Application: Assessment and Decision - CTIS Training Programme: Module 08 (Version 1.5)	Final	Clinical Trials, Procedural
EU	EMA	Introductory guide - CTIS for SMEs and Academia - CTIS Training Programme: Module 19 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	FAQs - Supervise a CT: Inspection records - CTIS Training Programme: Module 16 (Version 1.2)	Final	Clinical Trials, Inspections, Procedural
EU	EMA	FAQs - How to evaluate a Clinical Trial Application: Assessment and Decision - CTIS Training Programme: Module 08 (Version 1.5)	Final	Clinical Trials, Procedural
EU	EMA	FAQs - Support with workload management by workspace - CTIS Training Programme: Module 04 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	Frequently asked questions about parallel distribution (EMA/297155/2021 Rev. 2)	Final	Trade, Procedural, Application Process, Distribution
EU	EMA	Template or form: EudraVigilance Form B (EMA/99667/2016)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Template or form: EudraVigilance Form A (EMA/99666/2016)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Template for the notification of step 2 confirmatory testing outcome: confirmation of nitrosamine detected	Final	Procedural, Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev.115)	Final	Safety, Pharmacovigilance
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 100)	Final	Safety, Pharmacovigilance
EU	EMA	Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 3)	Final	Clinical, Medical, Antibiotics
EU	EMA	Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/CHMP/187859/2017)	Final	Clinical, Medical, Antibiotics
EU	EMA	Appendix 3 to the Guideline on the clinical evaluation of anticancer medicinal products - The Summary of Product Characteristics for an Anticancer medicinal product – mock-up of 4.8	Final	Oncology, Product Information, Safety
EU	EMA	Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages (EMA/670900/2020 Rev 10)	Final	Procedural, Product Information, Labeling
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/278150/2022)	Final	Product Information, Procedural
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.46)	Final	Procedural, Compliance, Administrative
EU	EMA	Mandatory use of ISO ICSR/ICH E2B(R3) and EDQM terminology for Dosage Forms (DF) and Routes of Administration (RoA) (EMA/580321/2021 Rev 1)	Final	Administrative, Pharmacovigilance, Safety, Procedural
EU	EMA	Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - EMBASE Search Strategies for Substance Groups 1-309, and Herbal Substance Groups 1-100 (EMA/517840/2015 Rev 4)	Final	Safety, Pharmacovigilance
EU	EMA	Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes (EMA/240473/2022)	Draft	Clinical, Medical
EU	EMA	Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product-specific bioequivalence guidance (EMA/CHMP/559891/2021)	Draft	Generics, Product Development
EU	EMA	IRIS guide for applicants (How to create and submit scientific applications, for industry and individual applicants) (EMA/444925/2018), Version 2.10	Final	Procedural, Application Process, Inspections, Orphans, Rare Diseases
EU	EMA	Public Consultation Concerning The Physical Attendance And The Location Of Personal Residency Of The Qualified Person (EMA/INS/169000/2022)	Draft	Compliance, Manufacturing, GMP, Quality, Safety, Efficacy
EU	EMA	Methodology for the establishment of lists of “main therapeutic groups” in crisis preparedness and of the lists of “critical medicines1” in the context of a major event and/or public health emergency (EMA/45332/2022)	Final	Supply, Distribution
EU	EMA	Timetable: Companion diagnostic initial consultation (EMA/3932/2022 Rev.1)	Final	Companion Diagnostics, Procedural
EU	EMA	Timetable: Companion diagnostic initial consultation – ATMP (EMA/3933/2022 Rev.1)	Final	Companion Diagnostics, Procedural, Cellular and Gene Therapy, Advanced Therapies
Ghana	Ghana FDA	Guidelines for reporting adverse drug reactions	Final	Safety, Pharmacovigilance
India	CDSCO	Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed	Final	Trade, Supply, Distribution
India	CDSCO	General Statutory Rule (GSR) 393(E) - Exemption under Schedule K of the Drugs Rules, 1945 for OTC drugs	Draft	Product Classification, Prescribing
India	CDSCO	General Statutory Rule (GSR) 382(E) - Parallel submission in Form 28-D	Draft	Import, Application Process, Manufacturing
India	CDSCO	General Statutory Rule (GSR) 357(E) - Inclusion of Acitretin in Schedule H of Drugs Rules 1945	Final	Product Classification, Switching
Ireland	HPRA	Registration of processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the Clinical Trials Regulation	Draft	Clinical Trials
Ireland	HPRA	Products availing of a derogation under Directive 2022/642/EC (post-Brexit)	Final	Supply, Compliance
Pakistan	DRAP	Good Distribution Practices for Pharmaceutical and Biological Drug Products (QALT/GL/DP/004), 1st Edition	Draft	Distribution, Supply
Pakistan	DRAP	Guidelines on categorization of GMP deficiencies (QMSC/GL/CG/000), 1st Edition	Draft	Manufacturing, GMP, Compliance, Inspections
Philippines	FDA Philippines	Implementing Guidelines on the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines	Draft	Application Process
Philippines	FDA Philippines	Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017	Draft	Procedural, Compliance
Philippines	FDA Philippines	Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines	Draft	Clinical Trials
Saudi Arabia	Saudi FDA	Guidelines for Variation Requirements (Version 6.2)	Final	Variations
Saudi Arabia	Saudi FDA	SFDA’s Product Specific Bioequivalence Guidance	Final	Bioequivalence, Clinical Trials, Efficacy, Generics, Product Development
Singapore	HSA	Guidance on therapeutic product registration in Singapore (TPB-GN-005-009)	Final	Application Process
Singapore	HSA	Common Questions related to generic drug applications	Final	Generics
Slovakia	SIDC	Update of application for transfer of a marketing authorisation for human medicinal product	Final	Application Process, Procedural
South Africa	SAHPRA	Risk Management Plans for Medicines for Human Use	Draft	Safety, Pharmacovigilance
South Africa	SAHPRA	Availability of Medicines for Use in a Public Health Emergency (PHE) (SAHPGL-PEM-01)	Final	Application Process, Supply
South Africa	SAHPRA	Application for rescheduling of a substance or medicine (SAHPGL-CEM-NS-01)	Final	Product Classification, Switching
South Africa	SAHPRA	Guideline to the scheduling of substances and medicines (SAHPGL-CEM-NS-02), Version 3	Final	Product Classification, Switching
South Africa	SAHPRA	Guideline to proprietary names for medicines (SAHPGL-CEM-NS-03), Version 7	Final	Procedural, Safety, Labeling
South Africa	SAHPRA	Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists (SAHPGL-CEM-NS-04), Version 3	Final	Prescribing
South Africa	SAHPRA	Guideline for lot release of human vaccines (SAHPGL-PEM-BIO-01), Version 2	Final	Quality, Vaccines
South Africa	SAHPRA	Pharmacovigilance systems (SAHPGL-CEM-PV-02), Version 1	Final	Safety, Pharmacovigilance
South Africa	SAHPRA	Pharmacovigilance Inspections for Human Medicinal Products (SAHPGL-CEM-PV-01), Version 1	Final	Safety, Pharmacovigilance, Inspections
Switzerland	Swissmedic	Out-of-Stock – COVID-19 – Authorisations for the temporary import and distribution of human medicines – Update	Final	Trade, Supply, Distribution
Switzerland	Swissmedic	Guidance document - Authorisation of human medicinal product with known active pharmaceutical substance HMV4	Final	Application Process, Procedural
Switzerland	Swissmedic	Updated information sheet on non-standardised medicinal products and on the list of non-standardised medicinal products and medicinal product groups with a manufacturing process subject to mandatory authorisation according to Annex 3 TPLO	Final	Procedural, Manufacturing
Tanzania	TMDA	Applications for renewal of marketing authorization of medicinal products	Final	Application Process, Procedural
UK	MHRA	MHRA phase I accreditation scheme	Final	Clinical Trials
UK	MHRA	The Northern Ireland MHRA Authorised Route (NIMAR)	Final	Supply, Procedural
UK	MHRA	Medicines shortages: regulatory processes to manage supply disruptions	Final	Supply, Procedural
US	FDA	Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues: Guidance for Industry	Final	Clinical, Medical
US	FDA	Importation of Prescription Drugs Final Rule - Questions and Answers: Small Entity Compliance Guide	Final	Trade, Supply
US	FDA	Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1): Guidance for Industry	Draft	Clinical, Antimicrobial
US	FDA	Risk Management Plans to Mitigate the Potential for Drug Shortages: Guidance for Industry	Draft	Quality, Manufacturing, GMP, Supply
US	FDA	Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Industry	Final	Labeling, Safety
US	FDA	Assessing User Fees Under the Generic Drug User Fee Amendments of 2017: Guidance for Industry	Final	Generics, User Fees, Application Process
US	FDA	Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Guidance for Industry	Final	Quality, Manufacturing, GMP
US	FDA	Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry	Draft	Quality, Chemistry, Manufacturing and Controls, CMC
US	FDA	Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Guidance for Industry	Draft	Clinical Pharmacology
US	FDA	Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components: Guidance for Industry	Final	Blood Products, Safety
US	FDA	Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Draft Guidance for Industry	Draft	Blood Products
US	FDA	Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Draft Guidance for Industry	Draft	Blood Products
US	FDA	Draft Guidance on Acetaminophen – Rectal (Suppository)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Arsenic Trioxide – Injectable (Injection)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Asenapine – Transdermal (System)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Bupivacaine – Infiltration (Solution, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Cedazuridine; Decitabine – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Chlorhexidine Gluconate – Dental (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Cocaine Hydrochloride – Nasal (Solution)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Exenatide Synthetic – Subcutaneous (For Suspension, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Exenatide Synthetic – Subcutaneous (Suspension, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Flunisolide – Nasal (Spray, Metered)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Halobetasol Propionate – Topical (Aerosol Foam)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate – Otic (Suspension/Drops)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ibuprofen – Oral (Suspension/Drops)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Lorazepam – Oral (Capsule, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Naloxone Hydrochloride – Nasal (Spray)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Oliceridine – Intravenous (Solution)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Palbociclib – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Pralsetinib – Oral (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Risdiplam – Oral (For Solution)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Secretin Synthetic Human – Intravenous (For Solution)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Solifenacin Succinate – Oral (Suspension)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tegaserod Maleate – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Torsemide – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Triheptanoin – Oral (Liquid)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Acarbose – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Doxorubicin Hydrochloride – Injection (Injectable, Liposomal)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Linaclotide – Oral (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Metoprolol Succinate – Oral (Capsule, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Midostaurin – Oral (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Oseltamivir Phosphate – Oral (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Selinexor – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Solifenacin Succinate – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Testosterone – Implantation (Pellets)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Theophylline – Oral (Tablet, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tiopronin – Oral (Tablet, Delayed Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Torsemide – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Trametinib Dimethyl Sulfoxide – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Uridine Triacetate – Oral (Granule)	Draft	Generics, Product Development

Global Pharma Guidance Tracker – May 2022

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