Governance

98 briefs

PIB ·

India amends Drugs Rules 1945 to regulate cell and gene therapy products as new drugs

Cell and gene therapy developers, manufacturers and importers in India must now meet the new-drug approval, clinical-trial and licensing requirements under the 2019 Rules — the amended Drugs Rules 1945 regulate these products as new drugs

ESMA ·

ESMA fines Moody's Germany €2,145,000 for four CRA-Regulation reporting breaches

EU-registered credit rating agencies must report complete, accurate rating data to ESMA and hold reporting policies, error-correction processes and internal controls to match — ESMA fined Moody's Germany €2,145,000 for failing all four

BaFin ·

BaFin imposes €620,000 administrative fines on VARTA AG for MAR and WpHG disclosure breaches

German issuers on organised markets must disclose inside information without undue delay and publish half-yearly reports within three months — BaFin fined VARTA AG €620,000 for failing both

FTC ·

FTC files order barring Havas from common-brand-safety agreements

US advertising agencies must not enter inter-agency agreements setting common brand-safety standards — the FTC's order bars Havas, completing action against all of the "Big Six"

RBI ·

Reserve Bank of India revises voluntary-surrender application for NBFC CoR

NBFCs (including HFCs) surrendering their Certificate of Registration must use the RBI's revised PRAVAAH application form and checklist, and must keep complying and filing returns until the RBI communicates cancellation in writing

EBA ·

EBA clarifies Product Oversight and Governance Guidelines for ESG retail banking products

Retail banking product manufacturers and distributors must meet clarified POG ESG and anti-greenwashing requirements across product design, target-market identification, distribution and disclosure

FINMA ·

FINMA revokes Swiss Fund Management AG's licence and bans an executive over FinSA suitability and conflict-of-interest breaches

Swiss asset managers and portfolio managers must run genuine FinSA suitability and appropriateness checks and disclose affiliate conflicts — FINMA revoked a fund manager's licence, refused another's authorisation and confiscated commission for selling clients in-house illiquid bonds

FTC ·

FTC orders Amazon to pay $2.25 million over FCRA identity-theft records failures

Companies holding transaction records must give identity-theft victims their application and business-transaction records within FCRA's 30-day limit — the FTC fined Amazon $2.25m for refusing

MAS ·

MAS amends SFA 04-N21 to permit alternative due-diligence steps for Global Listing Board issue managers

Issue managers on SGX-Nasdaq Global Listing Board listings may now use alternative due-diligence steps in place of the prescribed paragraph 23 procedures.