Country	Organization	Document	Status	Category
International	WHO	Emergency Use Listing Procedure	Final	Application Process, Procedural
Australia	TGA	Fees and charges proposal 2020-21	Draft	Application Process, Procedural
Australia	TGA	Notice of recommendations to prepare a document in substitution for the current Poisons Standard - New Chemical Entities (NCEs)	Final	Procedural
Australia	TGA	Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities (Version 3.1)	Final	Variations
Canada	HC	Product Monograph Implementation Plans	Final	Quality, Safety, Efficacy, Procedural
Denmark	DMA	Receipt control by wholesale distributors (GDP) - DHMA practice	Final	Distribution, Supply, Procedural
EU	CMDh	Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA)	Final	Application Process, Product Development, Procedural
EU	CMDh	Information on national timeslot booking systems and recommendations for requests to act as RMS (CMDh/020/2009/Rev.27)	Final	Application Process, Procedural
EU	EMA	European authorities working to avoid shortages of medicines due to Brexit – questions and answers (EMA/57821/2020 Rev 4)	Final	Procedural, Supply, Distribution
EU	EMA	Form: Presubmission request form for an EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application	Final	Procedural, Application Process
EU	EMA	Form: Marketing authorisation application (MAA) - pre-submission meeting request form (human) (EMA/571057/2018)	Final	Procedural, Application Process
EU	EMA	IRIS guide to registration - Version 2.2 (EMA/31242/2019)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/24287/2020)	Final	Product Information, Procedural
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 74)	Final	Inspections, Pharmacovigilance, Safety
EU	EMA	Form: Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use) - Forms 1-7	Final	Procedural, Safety
EU	EMA	Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders (EMA/457570/2019)	Draft	Manufacturing, Inspections
EU	EMA	Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency (EMA/533039/2019)	Final	Safety, Pharmacovigilance
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.18)	Final	Procedural, Compliance
EU	EMA	Confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology (EMA/561671/2019)	Final	Application Process, Procedural
EU	EMA	IRIS guide for Parallel Distribution applicants (EMA/444925/2018)	Final	Trade, Procedural, Application Process
EU	EMA	Frequently asked questions about parallel distribution	Final	Trade, Procedural, Application Process
EU	EMA	IRIS guide for applicants (how to create and submit scientific applications, for industry and individual applicants) Version 1.8 (EMA/444925/2018)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	Changing the name or address of a sponsor for an orphan designation	Final	Procedural, Orphans, Rare Diseases
EU	EMA	Applying for orphan designation	Final	Procedural, Orphans, Rare Diseases
EU	EMA	Removing an orphan designation	Final	Procedural, Orphans, Rare Diseases
India	CDSCO	Office Memorandum regarding grant of permission for carrying out overprinting/stickering/stamping of imported drugs in certain cases under the provisions of Rule 104A	Final	Labeling, Trade
India	CDSCO	Processing of Post Approval Changes to BA/BE permission issued in CT-07 and Import Licence issued in Form CT-17 for Export	Final	Clinical Trials, Quality, Safety, Efficacy
India	CDSCO	Notice regarding List of Reference Products for conduct of BE Study	Final	Clinical Trials, Quality, Safety, Efficacy
India	CDSCO	Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of Licenses/Permits/Certificates/Other Authorizations (LPCOs) by PGAs	Final	Administrative, Procedural, Application Process
India	DBT	Revised Simplified Procedures/ Guidelines on Import, Export and Exchange of GE organisms and products thereof for R&D purpose, 2020	Final	R&D, Product Development, Clinical Trials
India	DBT	Draft Document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment	Draft	Genomics
Lithuania	SMCA	Submission of Clinical Trials applications	Final	Clinical Trials, Procedural
Philippines	FDA Philippines	Amendment to FDA Circular No. 2019-003 Providing for the Guidelines on the Classification of Deficiencies Observed During Inspection of Drug Manufacturers	Draft	Compliance, Inspections, Manufacturing
Saudi Arabia	SFDA	The GCC Guidelines for Variation Requirements (Version 5.0)	Draft	Variations
Saudi Arabia	SFDA	Guidance for Paracetamol-Containing Liquid Dosage Forms Products Intended for Pediatrics	Draft	Pediatrics, Labeling, Safety
Saudi Arabia	SFDA	GVP - Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases (Version 3.0)	Final	Pediatrics, Vaccines
Switzerland	Swissmedic	Updated guidance document on: Authorisation according to Art. 14 para. 1 a^bis-quater TPA HMV4	Final	Application Process
Switzerland	Swissmedic	Questions and answers on Art. 14 para. 1 letter a^bis-quater TPA HMV4	Final	Application Process
Switzerland	Swissmedic	Notes on using Swissmedic templates for Information for healthcare professionals and Patient information	Final	Product Information, Procedural
Switzerland	Swissmedic	Template: Product Information for human medicinal products	Final	Product Information, Procedural
Switzerland	Swissmedic	Update of the form: PSUR/ PBRER for human medicines HMV4	Final	Pharmacovigilance, Safety
Switzerland	Swissmedic	Guidance document Drug Safety Signals HMV4	Final	Pharmacovigilance, Safety
Switzerland	Swissmedic	Guidance document Authorisation human medicinal product under Art. 13 TPA HMV4	Final	Application Process, Procedural
Tanzania	TMDA	Pilot testing of online system for submission of applications for registration of medical devices, premises, clinical trials and good manufacturing practices (GMP) inspections	Final	Procedural, Application Process
Uganda	NDA	Communication circular on Clinical Trial new format for CT certificates	Final	Clinical Trials
UK	MHRA	MHRA fees: Fees payable to MHRA for 2020 to 2021	Final	Administrative, Procedural
UK	MHRA	Valproate use by women and girls	Final	Safety, Pharmacovigilance
UK	MHRA	Advertise your medicines	Final	Advertising, Promotion
UK	MHRA	Export drugs and medicines: special rules	Final	Trade, Procedural
UK	MHRA	MHRA phase I accreditation scheme	Final	Clinical Trials, Good Clinical Practice
US	FDA	Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry	Final	Clinical, Medical
US	FDA	Assessing User Fees Under the Biosimilar User Fee Amendments of 2017: Guidance for Industry	Final	User Fees, Administrative, Procedural, Biosimilars
US	FDA	Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers: Guidance for Industry	Draft	Labeling, Promotion, Biosimilars
US	FDA	Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims	Final	Labeling
US	FDA	Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components: Draft Guidance for Industry	Draft	Blood Products
US	FDA	Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry	Final	Cellular and Gene Therapy, Advanced Therapies
US	FDA	Human Gene Therapy for Hemophilia: Guidance for Industry	Final	Cellular and Gene Therapy, Advanced Therapies
US	FDA	Human Gene Therapy for Rare Diseases: Guidance for Industry	Final	Cellular and Gene Therapy, Advanced Therapies, Orphans, Rare Diseases
US	FDA	Human Gene Therapy for Retinal Disorders: Guidance for Industry	Final	Cellular and Gene Therapy, Advanced Therapies
US	FDA	Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry	Final	Cellular and Gene Therapy, Advanced Therapies
US	FDA	Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up: Guidance for Industry	Final	Cellular and Gene Therapy, Advanced Therapies
US	FDA	Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Draft Guidance for Industry	Draft	Gene Therapy, Advanced Therapies, Orphans, Rare Diseases
US	FDA	Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions: Guidance for Industry	Final	Clinical, Pharmacology
US	FDA	In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions: Guidance for Industry	Final	Clinical, Pharmacology
US	FDA	Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act: Draft Guidance for Industry	Draft	Compounding, Manufacturing, Pharmaceutical Quality
US	FDA	Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 - Questions and Answers: Draft Guidance for Industry	Draft	Premarket, Administrative, Procedural, Pediatrics, Clinical Trials

Global Pharma Guidance Tracker – January 2020

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