Pharma Guidance Tracker - December 2015

Click on the links to access the documents.

Country	Organization	Document	Status
Australia	TGA	OTC new medicines registration process	Final
Australia	TGA	Process to change a registered OTC medicine	Final
Australia	TGA	Guidance for new registered complementary medicine applications - How to submit your application	Final
Australia	TGA	Regulation of biosimilar medicines	Final
Australia	TGA	Summary of fees and charges from 1 January 2016	Final
Australia	TGA	Adoption of EU Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances (EMA/448443/2014)	Draft
Australia	TGA	Adoption of EU Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing (EMA/CHMP/336243/2013)	Draft
Australia	TGA	Adoption of EU Guideline on the clinical investigation of hepatitis B immunoglobulins (EMA/CHMP/BPWP/585257/2009)	Draft
Australia	TGA	Adoption of EU Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) (EMA/CHMP/BPWP/410415/2011 rev 1)	Draft
Australia	TGA	Adoption of EU Guideline on clinical investigation of medicinal products for the treatment of acute heart failure (CPMP/EWP/2986/03 Rev. 1)	Draft
Australia	TGA	Adoption of EU Guideline on the adventitious agent safety of urine-derived medicinal products (EMA/CHMP/BWP/126802/2012)	Draft
Australia	TGA	Adoption of EU Guideline on non-clinical local tolerance testing of medicinal products (EMA/CHMP/SWP/2145/2000 Rev. 1, Corr. 1)	Draft
Canada	HC	Draft - Revised Guidance Document: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)	Draft
Canada	HC	Guidance Document - Ethnic Factors in the Acceptability of Foreign Clinical Data ICH Topic E5(R1)	Final
Canada	HC	Fees for the Review of Drug Submissions and Applications	Final
Canada	HC	Development Safety Update Report (DSUR) - International Conference on Harmonisation (ICH) Topic E2F	Final
Canada	HC	Questions and Answers Document - Structure and Content of Clinical Study Reports - ICH Topic E3 Q&A(R1)	Final
EU	CMDh	CMDh Procedural Advice on Validation Issues/National Requirements – Common grounds for invalidation/delaying validation (CMDh/075/2007/Rev 2)	Final
EU	CMDh	Q&A on Post-Authorisation Efficacy Studies (PAES) in MRP/DCP	Final
EU	EMA	Guideline on the clinical development of medicinal products intended for the treatment of pain (EMA/CHMP/970057/2011)	Draft
EU	EMA	Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations (EMA/CHMP/778709/2015)	Draft
EU	EMA	Guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis (ALS) (EMA/531686/2015)	Final
EU	EMA	Guideline on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy (EMA/CHMP/236981/2011)	Final
EU	EMA	EMA Procedural advice for users of the centralised procedure for generic/hybrid applications (Doc. Ref. EMEA/CHMP/225411/2006)	Final
EU	EMA	EMA Procedural advice for users of the Centralised Procedure for Similar Biological Medicinal Products applications (EMA/940451/2011)	Final
EU	EMA	European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (EMA/339324/2007)	Final
EU	EMA	European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMEA-H-19984/03 Rev.57)	Final
EU	EMA	Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: biological medicinal products (EMA/168402/2014)	Draft
EU	EMA	Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC) (EMA/334164/2015)	Draft
EU	EMA	Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1) (EMA/36988/2013 Rev. 1)	Final
EU	EMA	Guideline on the clinical investigation of medicinal products for the treatment of asthma (CHMP/EWP/2922/01 Rev.1)	Final
EU	EMA	Post-orphan medicinal product designation procedures (EMA/62801/2015 Rev. 1)	Final
EU	EMA	Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum I – Educational materials (EMA/61341/2015)	Final
EU	EMA	Guideline on good pharmacovigilance practices (GVP): Module XV – Safety communication (Rev. 1) (EMA/118465/2012)	Draft
EU	EMA	Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with final addendum I to module XVI on educational materials and, for public consultation draft revision 1 of module XV on safety communication with its templates and draft considerations P.II on biologicals, and in formation on the revised GVP structure (EMA/772189/2015)	Final
Ireland	HPRA	Guide to Invented Names of Human Medicines	Final
Ireland	HPRA	Guide to applying for a manufacturer's or importer's authorisation	Final
Netherlands	MEB	MEB 44: Direct Healthcare Professional Communications (DHPCs)	Final
Switzerland	Swissmedic	Modification of the procedure for applications to change the name and domicile of the authorisation holder and for transferring authorization	Final
UK	MHRA	Medicines: apply for a parallel import licence	Final
US	FDA	Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base	Draft
US	FDA	Head Lice Infestation: Developing Drugs for Topical Treatment	Draft
US	FDA	Best Practices for Communication Between IND Sponsors and FDA During Drug Development	Draft
US	FDA	Safety Assessment for IND Safety Reporting	Draft

Key

TGA: Therapeutic Goods Administration

HC: Health Canada

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

EMA: European Medicines Agency

HPRA: Health Products Regulatory Authority

MEB: Medicines Evaluation Board

Swissmedic: Swiss Agency for Therapeutic Products

MHRA: Medicines and Healthcare products Regulatory Agency

FDA: Food and Drug Administration