Pharma Guidance Tracker - May 2016

Click on the links to access the documents.

Country	Organization	Document	Status
International	WHO	Guidelines on validation (QAS/16.666)	Draft
International	ICH	ICH S3A Guideline: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies - Questions and Answers	Draft
Canada	HC	Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format	Final
EU	EDQM	Guidance for electronic submissions for Certificates of Suitability (CEPs) applications (PA/PH/CEP (09) 108, 3R)	Final
EU	CMDh	Question & Answers on ASMF (Track version)	Final
EU	CMDh	List of safety concerns per approved Risk Management Plan (RMP) of active substances per product	Final
EU	CMDh	Best Practice Guide Article 46 - EU Worksharing procedure (CMDh/138/2009/Rev.5) (Track version)	Final
EU	CMDh	Recommendations for implementing Commission Decisions following an Art. 29 Application under the Paediatric Regulation (CMDh/019/2009/Rev.3) (Track version)	Final
EU	CMDh	Member state agreement upon conditions under which the RMS can start the MRP/DCP (CMDh/243/2011/Rev. 7) (Track version)	Final
EU	CMDh	Common Grounds for Invalidation/Delaying Validation (CMDh/075/2007/Rev.3) (Track Version)	Final
EU	CMDh	CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (CMDh/077/2008/Rev.3) (Track version)	Final
EU	CMDh	CMDh Questions & Answers: Generic Applications (CMDh/272/2012, Rev.1) (Track version)	Final
EU	CMDh	Position paper on the use of the Quick Response (QR) codes to provide information about the medicinal product (CMDh/313/2014, Rev.4 ) (Track version)	Final
EU	CMDh	CMDh BPG on CMDh Recommendations on Unforeseen Variations (CMDh/298/2013, Rev.20) (Track version)	Final
EU	CMDh	CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008	Final
EU	EMA	Adoption of ICH guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers (EMA/CHMP/ICH/320985/2016)	Draft
EU	EMA	Day 80 assessment report overview guidance - generics rev. 3.16	Final
EU	EMA	Day 80 assessment report generics quality guidance rev. 3.16	Final
EU	EMA	Day 80 assessment report non-clinical and clinical guidance - generics rev. 3.16	Final
EU	EMA	D80 assessment report - Overview guidance rev. 3.16	Final
EU	EMA	D80 assessment report - Clinical guidance rev. 3.16	Final
EU	EMA	D80 assessment report - Non-clinical guidance rev. 3.16	Final
EU	EMA	Day 80 assessment report - Quality guidance	Final
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/324508/2016)	Final
EU	EMA	Guidance for implementation of eligibility requirements (EMA/253387/2015 rev. 1)	Final
EU	EMA	Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when (EMA/515416/2015)	Final
EU	EMA	Draft reflection paper on the dissolution specification for generic oral immediate release products (EMA/CHMP/CVMP/ QWP/37330/2016)	Draft
EU	EMA	Draft information in the package leaflet for fragrances containing allergens in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1)	Draft
EU	EMA	Draft information in the package leaflet for fructose and sorbitol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1)	Draft
EU	EMA	Draft information in the package leaflet for aspartame in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1)	Draft
EU	EMA	Concept paper on the revision of the 'Guideline on the environmental risk assessment of medicinal products for human use' (EMA/CHMP/SWP/ 65429/2016)	Draft
EU	EMA	Draft guideline on good pharmacogenomic practice (EMA/CHMP/268544/2016)	Draft
EU	EMA	Draft Everolimus tablets 0.25, 0.5, 0.75 and 1mg; 2.5, 5 and 10mg, dispersible tablets 0.1 and 0.25mg; 2, 3 and 5mg product-specific bioequivalence guidance (EMA/CHMP/154772/2016)	Draft
EU	EMA	Draft Fingolimod capsules 0.5mg product-specific bioequivalence guidance (EMA/CHMP/154812/2016)	Draft
EU	EMA	Draft Paliperidone prolonged-release tablet 1.5mg, 3mg, 6mg, 9mg and 12mg product-specific bioequivalence guidance (EMA/CHMP/154812/2016)	Draft
EU	EMA	Draft Pazopanib film-coated tablet 200mg and 400mg product-specific bioequivalence guidance (EMA/CHMP/154805/2016)	Draft
EU	EMA	Draft Levodopa/Carbidopa/Entacapone film-coated tablet 200mg/50mg/200mg, 175mg/43.75mg/200mg, 150mg/37.5mg/200mg, 125mg/31.25mg/200mg, 100mg/25mg/200mg, 75mg/18.75mg/200mg and 50mg/12.5mg/200mg product-specific bioequivalence guidance (EMA/CHMP/162889/2016)	Draft
EU	EMA	Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (EMA/CHMP/BWP/ 187338/2014)	Final
EU	EMA	Reflection paper on collecting and reporting information on off-label use in pharmacovigilance (EMA/293194/2016)	Draft
Ireland	HPRA	Guide to Labels and Leaflets of Human Medicines (AUT-G0034-17)	Final
Ireland	HPRA	Guide to Parallel Imports - Human Medicines (AUT-G0006-12)	Final
Japan	PMDA	Q&A on Post-marketing Reports of Adverse Drug Reaction, etc. and Clinical Trial Reports of Adverse Drug Reaction, etc. Conforming to Implementation Guide of E2B (R3)	Final
Latvia	SAM	Submission and agreement of Direct Healthcare Professional Communications with the State Agency of Medicines	Final
Latvia	SAM	Submission of educational materials laid down in the risk management plan to the State Agency of Medicines and their agreement	Final
Latvia	SAM	The State Agency of Medicines (SAM) recommended checklist – Addendum No. 1	Final
South Africa	MCC	Wholesalers to export medicinal products	Final
South Africa	MCC	Clinical trial oversight, monitoring of clinical trials (risk-based monitoring)	Draft
South Africa	MCC	Post clinical trial drug access	Draft
South Africa	MCC	Proposal to reschedule ephedrine, ephedra alkaloids and phenylpropanolamine	Draft
UK	MHRA	Medicines: apply for a variation to your marketing authorization	Final
UK	MHRA	Medicines: apply for a parallel import licence	Final
UK	MHRA	MHRA phase I accreditation scheme	Final
UK	MHRA	Send and receive information on adverse drug reactions (ADRs)	Final
UK	MHRA	Apply for the early access to medicines scheme (EAMS)	Final
UK	MHRA	Good clinical practice for clinical trials	Final
UK	MHRA	Decide if your product is a medicine or a medical device	Final
UK	MHRA	Good manufacturing practice and good distribution practice	Final
US	FDA	Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs: Draft Guidance for Industry	Draft
US	FDA	Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment Guidance for Industry	Draft
US	FDA	Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry	Draft
US	FDA	Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification: Guidance for Industry	Final
US	FDA	Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment - Guidance for Industry	Draft
US	FDA	Special Protocol Assessment: Guidance for Industry	Draft

Key

WHO: World Health Organization

ICH: International Council for Harmonisation

HC: Health Canada

EDQM: European Directorate for the Quality of Medicines

CMDh: Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human

EMA: European Medicines Agency

HPRA: Health Products Regulatory Authority

PMDA: Pharmaceuticals and Medical Devices Agency

SAM: State Agency of Medicines

MCC: Medicines Control Council

MHRA: Medicines and Healthcare products Regulatory Agency

FDA: Food and Drug Administration