Publications

Hogan Lovells Publications

Latest developments: National Health Insurance Bill

Earlier today, Health Minister Dr Aaron Motsoaledi convened a media briefing to discuss the release of the highly anticipated National Health Insurance Bill (NHI Bill), which has been...

Published Works

The South African pharmaceutical regulatory environment

Our local pharmaceutical environment is highly regulated. The most important legislative provisions are found in the Medicines Act and the Pharmacy Act.

Hogan Lovells Publications

Life sciences globalization fuels new developments in international arbitration

As they expand into new markets, companies are increasingly turning to international arbitration as a way to circumvent foreign court systems and speed up dispute resolution.

Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

Hogan Lovells Publications

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket...

Published Works

AHLA fundamentals of health law, seventh edition

A comprehensive resource for individuals who need to understand not only fundamental health law requirements, but also the complex web of legal relationships among patients, providers,...

Hogan Lovells Publications

New scientific data rules in China: China claims "data sovereignty"

In March of this year, the State Council released the Scientific Data Administrative Measures, a set of rules with the seemingly innocuous aim of collecting and making public the results of ...

Hogan Lovells Publications

FDA proposes streamlining combination product regulations

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule...

;
Loading data