CIOMS XIII: RWD & RWE

CIOMS has published a new report entitled: “Real-world data (RWD) and real-world evidence (RWE) in regulatory decision making”.

ICH draft M14: RWD

ICH has published the M14 draft Guideline entitled “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines”.

FDA REMS Logic Model

The FDA has published a new draft guidance for comments, which provides a systematic, structured approach to the design, implementation, and evaluation of a REMS.

Zimbabwe: PV Guideline

The Medicines Control Authority of Zimbabwe (MCAZ) has published a revised version of its “Pharmacovigilance Guideline for Pharmaceutical Industry”.

CIOMS: SCARs

CIOMS has published a new draft report on Severe Cutaneous Adverse Reactions (SCARs), which covers various aspects including diagnosis and causality assessment.

EMA: New RWE guidance

The EMA has published a couple of guidance documents regarding the use of RWE, which includes a draft reflection paper on the use of RWD in non-interventional studies to generate RWE.

EMA: Reproduction and Lactation

The EMA has published a new concept paper on a proposal to revise the 2008 Guideline on “Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling”.

MHRA & E2B(R3)

The MHRA has published new information on the submission of ICSRs, which describes the plans for the implementation of the ICH E2B(R3) standard in the MHRA database and its impact.

Swissmedic & E2B(R3)

Swissmedic has also published a note to inform MAHs about the plans for the migration of their ICSR submission systems to the E2B(R3) format.

CIOMS MLGs

CIOMS has published a new report, which is intended to address the need for a harmonized approach to the creation and use of MedDRA Labeling Groupings (MLGs) in product information.

FDA & E2B(R3)

Further to its January announcement regarding postmarketing ICSRs, the FDA has now announced that it is also accepting the submission of premarket ICSRs in the E2B(R3) format.

New Zealand

Medsafe has published a revised version of its Pharmacovigilance Guideline, which describes the Pharmacovigilance obligations of Pharma companies in New Zealand.

Singapore

The Health Sciences Authority (HSA) in Singapore has published a revised guideline on Post-Marketing Vigilance Requirements for Therapeutic Products.

Literature ICSRs & Day 0

The EMA has published a revised version of its guidance on the interpretation of the requirements regarding Day 0 for ICSRs described in local journals.