All Editorial articles

Editorial

Improving outcomes with data

03/04/24

Regulatory Rapporteur April 2024 | Volume 21 | No.4 Data, the focus topic for this month’s journal, brings together a range of articles which are underpinned by one uniting factor: our absolute dependence on it. Perhaps, ...

Editorial

Diverse and dynamic regulation in the Asia Pacific region

06/03/24

Regulatory Rapporteur March 2024 | Volume 21 | No.3 Our first regionally focused issue for 2024 metaphorically travels to the Asia-Pacific (APAC) region. Asia makes up 60% of the global population and there are a large number of regulatory ...

Editorial

Sink or swim: the changing tides of device regulation

08/02/24

 

Editorial

The increasing complexity of biological medicinal products

05/01/24

Regulatory Rapporteur January 2024 | Volume 21 | No.1 The world of biologics is shifting rapidly. In the more than 40 years since the introduction of the first biosynthetic human insulin in 1982, advances in scientific understanding and biotechnology ...

Editorial

Advancing global
healthcare together

05/12/23

An annual fixture since 2004, TOPRA’s Symposium is Europe’s premier conference for regulatory affairs professionals with dedicated programme streams for human and veterinary medicines, medical devices and IVDs. This year the Symposium was in Lisbon, in partnership with Infarmed, Portugal’s national authority of medicines and health products. 

Editorial

Editorial - November 2023

03/11/23

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Editorial

Veterinary medicines: the challenges of new regulation

02/10/23

Regulatory Rapporteur October 2023 | Volume 20 | No.9 The October 2023 edition of TOPRA’s journal – Regulatory Rapporteur – focuses on topics and developments specific for veterinary medicines: From the challenging aspects arising ...

Editorial

The worldwide web of regulation

01/09/23

In this issue, we focus on the pharmaceutical supply chain and the interaction of this function with regulatory. The supply chain team are the link between the manufacturer and the customer, and they are impacted by the complexity of regulations across different global markets and work with regulatory colleagues to ...

Editorial

Equal access to medicines:
finding the balance

Regulatory Rapporteur July/August 2023 | Volume 20 | No.7 This edition of TOPRA’s Regulatory Rapporteur journal explores some of the challenges faced by regulatory professionals around the world; from the African regulatory ecosystems, to health technology assessment (HTA), and the ongoing ...

Editorial

Clinical trials:
Ethical, ecological
and economic change

23/06/23

In the pursuit of global – or even regional – standards in requirements to support medical product development; is industry keeping up? Can regulations and guidelines keep up with the pace of change?

Editorial

Mind the gap:
Innovation vs
regulation of ATMPs

18/05/23

Technology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.

Editorial

The region walking the regulatory walk

06/04/23

Latin America (LATAM) is a large market with considerable promise for pharmaceutical growth, with a total potential patient population of more than 600 million people. The landscape in Latin America is changing quickly with demand growing as populations age and chronic diseases become commonplace.

Editorial

Setting the right standards

07/03/23

The theme of this issue is global standards but – as the contents reflect – the process by which documents and data become ‘standardised’ is anything but homogeneous or harmonised.

Editorial

The need for robust quality management

07/02/23

It is a simple fact that the establishment of a robust quality management system (QMS) can both drive – as well as facilitate – regulatory compliance across all layers of business and operations in the pharma and MedTech industries. However, there is no doubt that the mention of QMS can ...

Editorial

Patient evidence and engagement

04/01/23

Don’t we in Life Sciences excel at generating abbreviations and acronyms? For example, do you know your COA from your PED or PPI? Or PEE from PRO? If you don’t, an explanation will be forthcoming in this edition of the Regulatory Rapporteur.

Editorial

Waltzing into change in Vienna:
The regulatory future comes into focus

05/12/22

It is the most wonderful time of the year – yes, that is Symposium issue time – and the Regulatory Rapporteur editorial team never want to disappoint! The TOPRA Symposium is one of the major annual events for those working in regulatory affairs, and the 2022 Symposium – hosted in ...

Editorial

Adapting, transforming and innovating

31/10/22

For the past two years, global regulatory authorities have faced an un usual set of circumstances – navigating a pandemic while simultaneously producing more advice, guidance and regulations than ever be fore. The COVID-19 pandemic forced authorities to introduce new processes very quickly, and work closely with other authorities, public ...

Editorial

Great expectations for medical technologies

16/09/22

Few would dispute that the medical technology regulatory system continues to creak under the strain imposed by the regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746). At the time of going to print, the Medical Device Coordination Group (MDCG) issued proposed ...

Editorial

Regulatory operations: Evolution and revolution

22/08/22

 ‘Operations’ does not quite do justice to the critical role that these individuals play in the global team

Editorial

A new era of digital and data-driven innovations

16/06/22

Such significant advances in information management and technology are providing us with sophisticated tools and new ways of working