Differences between IND Annual Report and Annual Safety Report

IND Annual Report :

purpose- progress report
Timing- IND anniversary date
Frequency- annual
Recipients- FDA
Content- study data and summary information
Feedback by may be requested regulators: may be requested
Short term end of study report safety report within trials end of study report safety report within trials for all trials within 90 days 1 year of end
Adverse events included: all serious ± associated± expected
Format and Summary: Content, Tabular summary of most frequent and most serious AEs by body system. Summary of all IND expedited reports for the period. Lists of deaths (w/ cause) and dropouts. List of completed non-clinical studies and result summary.

Annual Safety Report:

Purpose-benefit-risk assessment
Timing- Date of 1st authorization of a clinical trial of IMP by authority in member state
Frequency-annual, or on request
Recipients- EMEA, Member States, Ethics Committees
Content- benefit-risk assessment;
Content- supporting tables
Feedback by may be requested regulators:not mentioned
Short term end of study report safety report within trials: safety report within trials for all trials within 90 days
Adverse events included SUSARs; serious,associated; ± expected
Format and Summary Content: Concise global analysis; benefit-risk evaluation; implications for trial subjects; proposed measures to minimize risk; rationale for updates of study documents and procedures; supporting results of non-clinical studies; other considerations

MedDRA

MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA is used in the US, European Union, and Japan. Its use is currently mandated in US, Europe and Japan for safety reporting.

MedDRA was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee.

MedDRA is managed by the MSSO (Maintenance and Support Services Organization).

Reference: ICH Guidelines

ICH - Multidisciplinary Topics

Multidisciplinary topics are categorized in to five types:

ICH M1: MedDRA(Medical Dictionary)

ICH M2: ESTRI(Electronic Standards for the Transfer of Regulatory Information)

ICH M3:  Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals

ICH M4: CTD(Common Technical Document)

ICH M5: Data Elements and Standards for Drug Dictionaries

Source: http://www.ich.org/UrlGrpServer.jser?@_ID=2196&@_FORCETEMPLATE=272

ICH(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)

 ICH topics are divided in to 4 major types:

1. "Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc.)

 2."Safety" Topics, i.e., those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.)

3."Efficacy" Topics, i.e., those relating to clinical studies in human subject (Dose Response Studies, Good Clinical Practices, etc.)

4."Multidisciplinary" Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above categories (MedDRA, ESTRI, M3, CTD, M5)

 Source: https://www.ich.org/cache/html/250-272-1.html

Pharmacovigilance- various inputs,processes and outputs

INPUTS: Safety data: spontaneous ADRs, epidemiology studies, clinical trials,  pre-clinical data.

PROCESSES : Signal generation, Signal evaluation, Risk–benefit review, Expert advice, Decision-making

OUTPUTS:Decision, Communication, revised SPC, revised PIL, bulletin article.