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What are the regulatory affairs today?

Sante DI Renzo

It is a lesson from great masters that the more you know a subject the easier you will be able to explain it. Those who really own the art and secrets of something can make it even very simple to the eyes and ears of laypeople.

I have been living and working in this sector, called “regulatory affairs” or “regulatory consultancy” for 50 years now.

I said “living” as well as “working” because I am so integrated and interpenetrated into the shades of this fascinating job, that it can be said that I breathe it, I own it, I cultivate it as if it was actually something alive.

And as far as it is difficult to believe it, the norms – any norm – are really something living, interpretable, usable and indefinite.

It is rarely only matter of strict written rules, because behind each of them there is a packed history of praxis, customs and traditions, social and economic trends and developments. But above all, there is much “future”. Rules always dig a furrow for the future, never for the past.

The progress of the regulatory sector

In particular, the regulatory sector has been the star of an incredible regulating acceleration, in the last 20 years, also and especially as consequence of a widening of the markets and national and legislative borders.

I still remember when this job did not have in Italy a dignity such as to have its own name. One talked of “proxies”, i.e. people who went to the Ministry of Health to “take care” of the procedures submitted by companies. Not a proper activity then, rather a person.

Most companies usually had their own trusted man, to be entrusted with this task. There was no need for the proxy to have a good knowledge of the norms – that at that time were also sufficiently limited.

They rather needed to be familiar with the Ministry praxis and processes to obtain the requested authorisations as quick as possible.

Many factors altered this way of acting. First the introduction of the fax, then the computer and finally the development of the several European regulations.

The “death” of the proxies was a painless agony that devaluated and deleted any usefulness of such role, with no special or quick revolution: more simply, what was delivered by hand was then sent via fax and, today, as certified e-mail.

The new regulations’ complexity, that was the real revolution of this sector: now you need to know what you are talking about, and you need to know it well, because submitting a procedure to the Ministry, to the AIFA or to other Agencies, is only the last remaining piece in the “preparation” of the procedure itself.

Activities are born out of needs

Usually, progresses of a certain activity do not take place through a specific planning: they are born out of the moment’s needs and the market’s future developments.

Some people are capable to answer as requested before and better than others, without even realising it, thus contributing to the slow change in how work is organised.

The changes taking place in the surrounding world – and therefore in one’s working picture – can be faced osmotically, following the flow of the events, so that people and their way of working change, imperceptibly, based on the actual needs.

However, if one pays attention to and is aware of the secrets of their own jobs, they can anticipate such change and be found ready, with the right solution at the most suitable time.

Our surroundings talk to us. We need to learn how to listen and interpret. It is not simple and most of the times it does not happen rationally, it is rather some sort of instinct. It happens for some sort of rather unconscious influence, though with very clear goals.

Regulatory affairs, as set up today, is no more an individual competence: they require the presence of more players, possibly with a different type of technical, scientific and administrative culture, and a good level of languages, because European, national and extra-EU regulations must be known very well. 

The borders of our work are now wide open, and keeping up with such novelties is not for everyone. One needs flexibility, learning, continuous update and a lot of curiosity.

The expert/applicant relation

Experts from a certain sector are not born by chance, if there is no demand. A dynamic relation is established between the two market partners – the expert and the applicant.

So it happened in the regulatory affairs world, where more and more complex norms and praxes have decidedly contributed to a revolution in the demands.

In very few years we went from the simple proxy to the regulatory expert. Then the practice of regulatory consultancy has arrived, that is able to face business strategies more chorally.

From a little gratifying activity – moving across Ministry’s corridors – we got to sit at the table of the people taking decisions for the company’s future.

It is a dialogue fed with shared goals and actual competence: we noted that the cooperation and discussions between our regulatory experts and our client companies go as far as the mutual culture and knowledge go.

In recent times something even more innovative is happening, and not everybody doing our job has actually realised it. 

At Di Renzo Regulatory Affairs we are ready to accept new challenges: our organisation currently consists of almost 100 people with different academic training.

We cooperate with hundreds of companies all over the world, in a global, wide and cogent vision, in the sector of medicines, medical devices, food supplements, cosmetics and biocides. And the good thing is that we are not yet tired of changing.

Written by Sante Di Renzo on 21/04/2023