What is standing in the way of global harmonisation?

Part I: The Global Pharmaceutical Regulatory Affairs State of the Industry Report 2020

What is standing in the way of global harmonisation?

This February, Informa Connect and Pink Sheet at Informa Pharma Intelligence surveyed pharmaceutical regulatory professionals from around the world. Over 160 respondents from across pharma, biotech, software firms and law told us which hurdles they saw in global regulatory affairs.

78% of the survey respondents were based in Europe. The remaining were based in Asia (8%), Middle East (6%), North America (4%), S America (2%) and Africa (2%).

The majority worked in pharma and biotech companies and just over half in organisations with 500 or more employees. 16% are employed by software providers/consultancies, and 9% in law firms.

53% held roles in regulatory affairs within their organisations, 20% in regulatory operations and 11% in information management.

As part of the survey, we asked what was the major obstacle in the way of globally harmonising pharmaceutical regulatory affairs.

Politics

Amongst the responses, politics stood out as the most mentioned barrier for global harmonisation, with nationalism and competition between authorities as a common theme.

"All sites prefer their own way."

"Competing interests among the various regulatory authorities."

"Different approaches (for instance data analysis versus checking the interpretation of the company), the level of trust in the companies, the responsibility of each individual state towards the protection of health of their citizens, data not being transparent."

"Different national healthcare systems and loss of influence for local politicians."

"Different regulations, different practices, sometimes proudness, and lack of knowledge about industry's struggles."

"Egoism of countries putting themselves on a higher shelf."

"Individuality of countries/cultures, as long as it is not mandatory there will always be institutions who will do things their own way."

"National reasons, national sovereignty, each agency makes its own thing and creates its own requirements."

"Polítical decision /interest on the executive branches of government."

"The political landscape, the ease at which pharma is willing to pay for unnecessary inspections for individual countries just to keep the licence in that specific country. HA's are making easy money with these unnecessary audits - the country we are in (EU member) should be recognised already for the very tough HA inspection from our own country."

"Trade war between China and USA, as well as the policies of the Russian Federation."

Regulations & Law

Alongside political interests, respondents recognised the unique requirements and cultures of each country as an important sticking point. Some even indicated a divide between eastern and western regions.

"Big differences between the local regulations."

"Consistency in the manner in which medicines are evaluated and the requirements for registration."

"Country-specific legislation."

"Different requirements in terms of variations controls."

"EU and USFDA."

"Cultural differences."

"Different levels of quality and standards and language (although this is becoming less so with the auto translation facilities progressively improving)."

"Major Growth countries like China and India needs to be more aligned towards ICH and CTD."

"Standard of developed region vs market attraction of developing region."

"Too many countries."

Technology / Expertise

A large number of respondents highlighted that technological challenges were either all or partly to blame for the delay in harmonisation across different countries. Examples included lack of software, infrastructure and data formats alongside levels of expertise and training within local industries.

"Complexity of migration of legacy data/documents/sequences to new harmonized system. Usage of different information management system and the problem of synchronized harmonization (eDMS, SAP, etc.). Financial aspect of systems upgrade and working hours needed for implementation."

"Data security. Differences and ingrained habits."

"Dossier format."

"Jobs reduction in HA level."

"Lack of expertise, and self-centric attitude."

"Lack of training (e.g. on global regulations, standards) and lack of awareness of the mutual benefits of harmonisation."

Industrial collaboration

Some respondents suggested that current levels of collaboration between organisations within the pharmaceutical industry were not sufficient to achieve regulatory harmonisation.

"Agencies not fully engaging with industries to determine way forward with not too much burden being placed on industries."

"Further collaboration between agencies."

"Lack of Capacities at authority. But the most important lack of understanding from authority and sometimes from industry side why Harmonisation is beneficial. Bias about losing the power of impact from particular local organisations."

Other respondents argued that financial challenges were underlying as a major barrier.

"Burden of cost in achieving harmonization, this cannot be borne solely by the industry."

Meanwhile, a few respondents remained confident that there were no real challenges delaying regulatory harmonisation.