Country	Organization	Document	Status	Category
International	WHO	WHO guidelines on the transfer of technology in pharmaceutical manufacturing (QAS/20.869/Rev1)	Draft	Manufacturing, GMP
International	WHO	Inquiry regarding WHO product-specific guidance on the design of bioequivalence studies (QAS/21.876)	Draft	Bioequivalence, Clinical Trials
Australia	TGA	Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Methyl salicylate	Draft	Labeling, Product Information
Australia	TGA	Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Lidocaine (lignocaine)	Draft	Labeling, Product Information
Australia	TGA	Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines	Draft	Labeling, Product Information
Australia	TGA	Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Menthol	Draft	Labeling, Product Information
Australia	TGA	New standard for serialisation and data matrix codes on medicines	Final	Safety, Labeling, Supply
Australia	TGA	Medicine labels: Guidance on TGO 91 and TGO 92 (Version 2.3)	Final	Supply, Trade, Labeling, Compliance, Product Information
Australia	TGA	Tips on creating prescription medicine labels compliant with TGO 91	Final	Supply, Trade, Labeling, Compliance, Product Information
Belgium	FAMHP	Manufacturing and distribution authorisations and registrations of active pharmaceutical ingredients (API) distributed digitally	Final	Manufacturing, GMP, Distribution, Procedural
Canada	HC	Updated requirements for COVID-19 drug authorizations: Notice	Final	Procedural
Canada	HC	Electronic media in prescription drug labelling	Draft	Labeling, Product Information
Canada	HC	Guidance for completing the Drug Submission Application Form	Final	Application Process, Procedural
Canada	HC	Expiration Dating for Medical Gases	Final	Labeling, Compliance
Czech Republic	SÚKL	COVID-19 Vaccination in Non-COVID Clinical Trials	Final	Clinical Trials
Czech Republic	SÚKL	Application for renewal of parallel import authorisation (REG-95, Version 1)	Final	Trade, Procedural, Labeling, Packaging
Czech Republic	SÚKL	Application for parallel import authorisation (REG-87, Version 3)	Final	Trade, Procedural, Labeling, Packaging
Czech Republic	SÚKL	Notification of the commencement of distribution activities within the territory of the Czech Republic based upon distribution authorization for medicinal products issued by another EU member state - after Brexit	Final	Distribution, Supply, Trade
Denmark	DMA	Notification of serious or repeated non-compliance with good clinical practice in clinical trials	Final	Clinical Trials
EU	OCABR	Guideline for Pandemic COVID-19 Vaccine (mRNA Vaccine)	Final	Quality, Safety, Vaccines
EU	EDQM	How CEP holders can avoid the rejection of notifications	Final	Manufacturing, GMP, Procedural
EU	EDQM	Revision of CEPs referring to one of the “sartan” monographs following their rapid implementation	Final	Quality, Safety, Manufacturing, GMP, Procedural
EU	EU	An EU programme of COVID-19 convalescent plasma collection and transfusion - Guidance on collection, testing, processing, storage, distribution and monitored use	Final	Safety, Quality
EU	CMDh	List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (Doc. Ref: CMDh/330/2015, Rev.31)	Final	Safety, Pharmacovigilance
EU	EMA	EU Individual Case Safety Report (ICSR)1 Implementation Guide (EMA/51938/2013 Rev 2)	Final	Safety, Pharmacovigilance
EU	EMA	EU E2B (R3) testing files (EDQM revision)	Final	Final
EU	EMA	EU reference instances (EDQM revision)	Final	Safety, Pharmacovigilance
EU	EMA	EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets	Final	Safety, Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (EMA/136148/2012, Rev.59)	Final	Safety, Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (EMA/136157/2012, Rev.27)	Final	Safety, Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (EMA/136156/2012, Rev.58)	Final	Safety, Pharmacovigilance
EU	EMA	Explanatory note on general fees payable to the European Medicines Agency	Final	Application Process, Procedural
EU	EMA	New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 March 2021 PRAC (EMA/PRAC/146288/2021)	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev.101)	Final	Safety, Pharmacovigilance
EU	EMA	Template or form: Presubmission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application	Final	Procedural, Application Process
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 87)	Final	Safety, Pharmacovigilance
EU	EMA	Questions & Answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device (EMA/144066/2021 Rev. 1)	Final	Combination Products, Procedural
EU	EMA	Template or form: Application form for consultation by a notified body on an ancillary medicinal substance/ancillary human blood or plasma derivative used in a medical device (EMA/75225/2020)	Final	Combination Products, Procedural
EU	EMA	Template or form: Application form for a post-consultation procedure on an ancillary medicinal substance in a medical device (EMA/75252/2020)	Final	Combination Products, Procedural
EU	EMA	Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2021/2022 (EMA/CHMP/BWP/80561/2021)	Final	Vaccines
EU	EMA	EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines (EMA/213341/2020 Rev.1)	Final	Application Process, Procedural, Product Development
EU	EMA	European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMEA-H-19984/03 Rev. 90) [Track version]	Final	Procedural, Safety, Pharmacovigilance, Variations
EU	EMA	European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (EMA/821278/2015) [Track version]	Final	Procedural, Application Process
EU	EMA	Inclusion/exclusion criteria for the “Important Medical Events” list (EMA/126913/2021)	Final	Safety, Pharmacovigilance
EU	EMA	Important medical event terms list version (MedDRA) - version 24.0 (EMA/166747/2021)	Final	Safety, Pharmacovigilance
EU	EMA	Template or form: Template - Active substance master file procedure	Final	Quality, Safety, Procedural
EU	EMA	ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use - Organisation of CTD: Step 5 (EMA/CPMP/ICH/2887/1999)	Final	Application Process, Procedural
EU	EMA	Template or form: Letter of recommendations – Template	Final	Compliance, Procedural
EU	EMA	Guidance on parallel consultation (EMA/410962/2017 Rev 4)	Final	Application Process, Procedural
EU	EMA	Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19 (EMA/133106/2021)	Final	Application Process, Procedural, Product Development
EU	EMA	CHMP Safety Working Party’s response to CMDh questions on chlorobutanol (EMA/CHMP/SWP/482438/2020)	Final	Safety, Quality
EU	EMA	EMA pharmacovigilance system manual (Version 1.3)	Final	Safety, Pharmacovigilance
EU	EMA	Labelling flexibilities for COVID-19 therapeutics (EMA/35618/2021)	Final	Labeling, Procedural
EU	EMA	IRIS guide to registration Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration (Version 2.5) (EMA/31242/2019)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	Quick interactive guide to IRIS registration process	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	IRIS guide for applicants (how to create and submit scientific applications, for industry and individual applicants) Version 1.11 (EMA/444925/2018)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	Questions and answers to Stakeholders on the implementation of the Protocol on Ireland/Northern Ireland (EMA/520875/2020)	Final	Procedural, Application Process, Administrative
EU	EMA	New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2021 PRAC (EMA/PRAC/82060/2021)	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	Questions & Answers on implementation: Impact of the Article 5(3) scientific opinion on nitrosamines in human medicinal products on the Opinion adopted pursuant to Article 31 of Directive 2001/83/EC for angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (candesartan, irbesartan, losartan, olmesartan, valsartan) (EMA/86733/2021)	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality, Variations
EU	EMA	Pilot project ‘Market Launch Intentions of Centrally Authorised Products’ - Practical Questions and Answers (EMA/90075/2021)	Final	Orphans, Procedural
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.32)	Final	Procedural, Compliance, Administrative
EU	EMA	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.2)	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	EMA	European Medicines Agency practical guidance on the application form for centralised type IA and IB variations (EMA/233564/2014 - Rev. 3)	Final	Variations
Ireland	HPRA	Guide to Clinical Trials Regulation-National Collaboration Project (AUT-G0159-1)	Final	Clinical Trials
Ireland	HPRA	Guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines (AUT-G0019-11) [Track version]	Final	Trade, Supply, Procedural
Japan	PMDA	Information on implementation of ICH Q3D into the Japanese Pharmacopoeia - Handling of Elemental Impurities in Prescription Drugs (Provisional Translation by Japanese Pharmacopoeia Secretariat)	Final	Quality, Safety
Japan	PMDA	Question and Answer (Q&A) about Handling of Elemental Impurities in Prescription Drugs (Provisional Translation by Japanese Pharmacopoeia Secretariat)	Final	Quality, Safety
Japan	PMDA	Guidelines on Cancer Immunotherapy Development (Provisional Translation)	Final	Oncology, Clinical, Medical
Lithuania	SMCA	Regarding medicinal products for which “sunset clause” may already be applied	Final	Procedural
New Zealand	Medsafe	Proposed changes to paracetamol warning and advisory statements	Final	Labeling, Product Information
Philippines	FDA Philippines	Extension of the effectivity of FDA Circular No. 2020-15, as amended, entitled “Interim measures to ensure access to vitamin drug products during the CoronaVirus disease 2019 (Covid-19) pandemic.”	Final	Application Process, Supply
Saudi Arabia	Saudi FDA	Guide to Good Manufacturing Practice for Medicinal Products (Version 4)	Final	GMP, Manufacturing
Saudi Arabia	Saudi FDA	Application for Variation to a Marketing Authorization	Final	Variations, Procedural
Singapore	HSA	Clinical Trials Guidance - Determination of whether a clinical trial requires Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC) (GN-IOCTB-01 Rev. No. 003)	Final	Clinical Trials
Singapore	HSA	Clinical Trials Guidance - Regulatory requirements for new applications and subsequent submissions (GN-IOCTB-04 Rev. No. 003)	Final	Clinical Trials
Singapore	HSA	Clinical Trials Guidance - Multi-Sponsor Investigator-Initiated Clinical Trials (GN-IOCTB-02 Rev. No. 002)	Final	Clinical Trials
Singapore	HSA	Clinical Trials Guidance - Clinical Research Materials (GN-IOCTB-03 Rev. No. 002)	Final	Clinical Trials
Singapore	HSA	Clinical Trials Guidance - Guidance on determining whether an amendment to a clinical trial is a substantial amendment (GN-IOCTB-05 Rev. No. 003)	Final	Clinical Trials
Singapore	HSA	Clinical Trials Guidance - Safeguards and consent requirements in vulnerable trial participants (GN-IOCTB-06 Rev. No. 003)	Final	Clinical Trials
Singapore	HSA	Clinical Trials Guidance - Labelling of investigational and auxiliary products in clinical trials (GN-IOCTB-07 Rev. No. 004)	Final	Clinical Trials, Labeling, Cellular and Gene Therapy, Advanced Therapies
Singapore	HSA	Clinical Trials Guidance – Expedited safety reporting requirements for clinical trials (GN-IOCTB-10 Rev. No. 002)	Final	Clinical Trials, Safety
Singapore	HSA	Clinical Trials Guidance – Notification of serious breach (GN-IOCTB-13 Rev. No. 002)	Final	Clinical Trials, Safety
Singapore	HSA	Clinical Trials Guidance – Electronic Consent (GN-IOCTB-14 Rev. No. 002)	Final	Clinical Trials
Singapore	HSA	Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products	Final	Clinical Trials, Cellular and Gene Therapy, Advanced Therapies
Singapore	HSA	Clinical Trials Guidance – Guidance on GCP compliance inspection framework (GN-IOCTB-11 Rev. No. 002)	Final	Clinical Trials, Inspections, Compliance
Singapore	HSA	Clinical Trials Guidance - Alternative measures for investigational product management for clinical trials of locally registered products (GN-IOCTB-08 Rev. No. 002)	Final	Clinical Trials
Singapore	HSA	Clinical Trials Guidance - Investigational product repackaging on site (GN-IOCTB-09 Rev. No. 002)	Final	Clinical Trials
Singapore	HSA	Cell, Tissue and Gene Therapy Products Guidance - Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore - Appendix 1: Guideline on notification process for Class 1 Cell, Tissue or Gene Therapy Product	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process
Singapore	HSA	Annex 1: Form to list Class 1 Cell Tissue or Gene Therapy Products (Version: ATPB-AN-001-000)	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore - Appendix 2: Pre-market consultation for Class 2 Cell, Tissue or Gene Therapy Product registration	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 3: NDA Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ICH CTD Format)	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 4: NDA Application Checklist for Class 2 Cell, Tissue or Gene Therapy Product (ACTD Format)	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 5: Sample Verification Document for Translator (ATPB-GN-005-000)	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 6: Target Processing Timelines for Class 2 CTGTP Applications	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 7: Points to Consider for Class 2 CTGTP Labelling	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process, Labeling
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Annex 2: Checklist for the registration of Class 2 Cell, Tissue or Gene Therapy Product containing materials of animal origin	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 8: Chemistry, Manufacturing and Controls requirements for Cell, Tissue or Gene Therapy Product for Clinical Trials and Product Registration	Final	Clinical Trials, Cellular and Gene Therapy, Advanced Therapies
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 9: Guideline on the Submission of Risk Management Plan Documents	Final	Cellular and Gene Therapy, Advanced Therapies, Safety, Pharmacovigilance
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 10: Guideline on Minor Variation (MIV) Application for Class 2 Cell, Tissue or Gene Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies, Variations
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Part A: Checklist on Dossier Requirements for MIV-1 Application	Final	Cellular and Gene Therapy, Advanced Therapies, Variations, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Part B Checklist on Dossier Requirements for MIV-2 Application	Final	Cellular and Gene Therapy, Advanced Therapies, Variations, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 11: Variation Application Filing and Submission Enquiry Form	Final	Cellular and Gene Therapy, Advanced Therapies, Variations, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 12: MAV-1 Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ICH CTD Format)	Final	Cellular and Gene Therapy, Advanced Therapies, Variations, Procedural
Singapore	HSA	Guidance on Cell, Tissue and Gene Therapy Products registration in Singapore – Appendix 13: MAV-1 Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ACTD Format)	Final	Cellular and Gene Therapy, Advanced Therapies, Variations, Procedural
Singapore	HSA	Guidance Notes on Good Distribution Practice	Final	Distribution, Supply, Cellular and Gene Therapy, Advanced Therapies
Singapore	HSA	HSA Guidelines on Good Manufacturing Practice for Cell, Tissue and Gene Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies, Manufacturing, GMP
Singapore	HSA	Guidance for Industry: Post-marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies, Safety, Pharmacovigilance
South Africa	SAHPRA	Guide to fee determination and payments of GXP and product-related inspections – Document for comment	Draft	Inspections, Compliance, Procedural, Manufacturing, GMP, Clinical Trials, GCP
South Africa	SAHPRA	Oversight and Monitoring in Clinical Trials (Version 3)	Final	Clinical Trials
South Africa	SAHPRA	Biological medicines amendment guideline (Version 4)	Final	Biologicals, Variations
Switzerland	Swissmedic	Out-of-Stock – COVID-19 – Authorisations for the temporary import and distribution of human medicines – Update	Final	Trade, Supply, Distribution
Tanzania	TMDA	Guidelines on Variations of Registered Vaccines (TMDA/DMC/MRE/G/014)	Final	Vaccines, Variations
Uganda	NDA	Guidance on the attributes of a valid proforma invoice when importing unregistered drugs	Final	Import, Supply
UK	MHRA	MHRA fees: Fees payable to the MHRA for 2021 to 2022	Final	Administrative, Procedural, Application Process
UK	MHRA	Types of application (legal basis)	Final	Procedural, Application Process
UK	MHRA	Good laboratory practice (GLP) for safety tests on chemicals	Final	Safety
UK	MHRA	Responding to a GLP and GCP laboratory inspection report	Final	Inspections, Compliance, Clinical Trials
UK	MHRA	Innovative Licensing and Access Pathway	Final	Application Process, Procedural
UK	MHRA	Electronic Application Form and Cover Letter Tool	Final	Application Process, Variations, Procedural
UK	MHRA	The Target Development Profile Toolkit	Final	Application Process, Procedural
UK	MHRA	Medicines: get scientific advice from MHRA	Final	Application Process, Procedural, Product Development
UK	MHRA	Good clinical practice for clinical trials	Final	Procedural, Clinical Trials
UK	MHRA	Make a payment to MHRA	Final	Procedural, Application Process
UK	MHRA	Guidance for industry on MHRA’s expectations for return to UK on-site inspections	Final	Inspections, Compliance
UK	MHRA	Clinical trials for medicines: manage your authorisation, report safety issues	Final	Clinical Trials
UK	MHRA	Clinical trials for medicines: apply for authorisation in the UK	Final	Clinical Trials, Application Process, Procedural
UK	MHRA	Managing clinical trials during Coronavirus (COVID-19)	Final	Clinical Trials
UK	MHRA	List of approved countries for authorised human medicines - Approved countries for batch testing and importation of medicines	Final	Trade, Quality, Procedural, Manufacturing, GMP
UK	MHRA	Importing medicines into Northern Ireland before 31 December 2021	Final	Trade, Supply, Procedural
UK	MHRA	Guidance for retailers: supplying medical devices to Northern Ireland	Final	Trade, Supply, Procedural
US	FDA	Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers: Guidance for Industry	Final	Generics
US	FDA	Draft Guidance on Bremelanotide Acetate - Solution (subcutaneous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Calcifediol - Capsule, Extended Release (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Cysteamine Bitartrate - Granule, Delayed Release (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Degarelix Acetate – Powder (Subcutaneous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Entrectinib – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ethinyl Estradiol; Levonorgestrel – Tablet (Oral): Two studies	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ethinyl Estradiol; Levonorgestrel – Tablet (Oral): One study	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fedratinib Hydrochloride – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ferric Maltol – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Guanfacine Hydrochloride – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Istradefylline – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ledipasvir; Sofosbuvir – Pellets (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Monomethyl Fumarate - Capsule, Delayed Release (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Octreotide Acetate - Capsule, Delayed Release (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Octreotide Acetate – Solution (Subcutaneous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Penicillin G Benzathine – Injectable (Injection)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Selinexor – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Siponimod Fumaric Acid – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Sofosbuvir – Pellets (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Solriamfetol Hydrochloride – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Testosterone Undecanoate – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Cannabidiol – Solution (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ciclesonide - Aerosol, Metered (Inhalation)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Doxycycline Hyclate – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fenoprofen Calcium – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ipratropium Bromide - Aerosol, Metered (Inhalation)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ivacaftor; Ivacaftor, Tezacaftor – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Labetalol Hydrochloride - Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Nitazoxanide – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Nitazoxanide - For Suspension (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Pazopanib Hydrochloride – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Regorafenib – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Guidance on Rucaparib Camsylate – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ursodiol – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ursodiol – Tablet (Oral)	Draft	Generics, Product Development

Global Pharma Guidance Tracker – March 2021

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