Pharma guidance tracker April-May 2015

Click on the links to access the documents

Country	Organization	Document	Status
International	WHO	Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions	Draft
Australia	TGA	Risk management plans	Final
Australia	TGA	Changes to sponsorship of therapeutic goods	Final
Australia	TGA	Guidance 15: Biopharmaceutic studies	Final
Canada	HC	Guidance Document on the Application for a Certificate of a Pharmaceutical Product (GUI-0024)	Final
Canada	HC	Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)	Final
Canada	HC	Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions	Final
EU	EC	Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use	Final
EU	EC	Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use	Final
EU	EC	EudraLex, Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (Annex 15: Qualification and Validation)	Final
EU	EMA	Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products	Draft
EU	EMA	Guideline on clinical development of fixed combination medicinal products	Draft
EU	EMA	Draft concept paper on the need to revise the "Guideline on the evaluation of anticancer medicinal products in man" in order to provide guidance on the reporting of safety data from clinical trials	Draft
EU	EMA	Guideline on good pharmacovigilance practices (GVP) - Module XVI addendum I – Educational materials	Draft
EU	EMA	Guideline on the chemistry of active substances	Draft
EU	EMA	Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances	Draft
EU	EMA	Concept paper on the development of a guideline on quality and equivalence of topical products	Draft
EU	EMA	Good practice guide on risk minimisation and prevention of medication errors	Draft
EU	EMA	Good practice guide on recording, coding, reporting and assessment of medication errors	Draft
EU	EMA	Risk minimisation strategy for high strength and fixed combination insulin products, addendum to the good practice guide on risk minimisation and prevention of medication errors	Draft
EU	EMA	Draft qualification opinion of qualification of exacerbations of chronic pulmonary disease tool (EXACT), and EXACT–respiratory symptoms measure (E–RS) for evaluating treatment outcomes in clinical trials in COPD	Draft
EU	EMA	Concept paper on clinical investigation of medicinal products for the treatment of axial spondyloarthritis	Draft
EU	EMA	Guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease	Draft
EU	EMA	Guidance for implementation of eligibility requirements: Criteria to be fulfilled by patients', consumers' and healthcare professionals' organisations for involvement in EMA activities	Final
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes	Final
EU	EMA	Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004. Chapter 3.II: XEVPRM User Guidance	Final
EU	EMA	European Medicines Agency post-authorisation procedural advice for users of the centralized procedure	Final
EU	EMA	Dossier requirements for Centrally Authorised Products (CAPs)	Final
EU	EMA	Guidance on the handling of declarations of interests in case of a scientific committee member/other (scientific) forum member's intention to become an employee in a pharmaceutical company	Final
EU	EMA	Procedural guidance on inclusion of declared interests in the European Medicines Agency's electronic declaration of interests form (for scientific committees’ members and experts)	Final
EU	EMA	Questions & answers on Article 31 pharmacovigilance referral procedures	Final
EU	EMA	Questions & answers on Article 20 pharmacovigilance procedures	Final
EU	EMA	Questions & answers on Urgent Union Procedures (Article 107i of Directive 2001/83/EC)	Final
EU	EMA	Presubmission guidance: questions 1 to 10	Final
EU	EMA	Guidance to applicants/marketing authorisation holders (MAHs) on oral explanations at EMA	Final
EU	EMA	Compilation of individual product-specific guidance on demonstration of bioequivalence	Final
Ireland	HPRA	Guide to Biosimilars for Healthcare Professionals and Patients	Draft
Ireland	HPRA	Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation	Final
Malaysia	NPCB	Drug Registration Guidance Document (DRGD)	Final
New Zealand	Medsafe	Guideline on the Regulation of Therapeutic Products in New Zealand. Part 8: Pharmacovigilance	Draft
Saudi Arabia	SFDA	Guideline on good pharmacovigilance practices (GVP) – Definition	Draft
Saudi Arabia	SFDA	Guideline on Good Pharmacovigilance Practices (GVP)	Draft
Saudi Arabia	SFDA	Guideline on good pharmacovigilance practices (GVP): Product-or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases	Draft
Saudi Arabia	SFDA	Regulations of Transporting and Storing Medication and Pharmaceutical products through Customs Ports	Final
Saudi Arabia	SFDA	Regulation and Requirements for Import, Clearance and Export	Final
UK	MHRA	Medicines: apply for a parallel import licence	Final
US	FDA	Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators	Draft
US	FDA	Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009	Draft
US	FDA	Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment	Draft
US	FDA	Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System	Draft
US	FDA	Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity	Draft
US	FDA	M8 Electronic Common Technical Document (eCTD) v4.0 DRAFT Implementation Guide v2.0; and eCTD Implementation Package DRAFT Specification for Submission Formats v2.0 (Adoption of ICH guideline)	Draft
US	FDA	Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs	Draft
US	FDA	Risk Evaluation and Mitigation Strategies: Modifications and Revisions	Draft
US	FDA	Development and Submission of Near Infrared Analytical Procedures	Draft
US	FDA	M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (Adoption of ICH guideline)	Final
US	FDA	ANDA Submissions – Refuse-to-Receive Standards	Final
US	FDA	Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications	Final
US	FDA	Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009	Final
US	FDA	Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product	Final
US	FDA	Scientific Considerations in Demonstrating Biosimilarity to a Reference Product	Final
US	FDA	Abuse-Deterrent Opioids – Evaluation and Labeling	Final

Key

WHO: World Health Organization

TGA: Therapeutic Goods Administration

HC: Health Canada

EC: European Commission

EMA: European Medicines Agency

HPRA: Health Products Regulatory Authority

NPCB: National Pharmaceutical Control Bureau

Medsafe: Medicines and Medical Devices Safety Authority

SFDA: Saudi Food and Drug Authority

MHRA: Medicines & Healthcare products Regulatory Agency

FDA: Food and Drug Administration