New pharma regulations


The annual QP (Qualificate People) meeting, set up by AFI, is at its XV edition. This is a moment of sharing and confrontation between pharmaceutical world and authority. The event offers food for thought and occasions for professional growth. The introduction of new pharma regulations, which have been debated a lot, is the main topic of the first two days of dialogue. Vittorio Tonus and Lino Pontello are the appointees to moderate the debate. They are API committee members, together with Massimo CavalieriPiero Iamartino and Giorgio Bruno, president of the association.

News in the pharma regulatory landscape

In the complex pharmaceutical world the role of the Qualificate Person is trasversal with respect to the corporate functions. This is why some regulations, that appear not to be involved into, actually have repercussion on this professional figure. This premise, together with a landscape about 2021 new pharma regulations Leonardo Gabrieli, starts the event.


Brexit created new bureaucratic obstacles, to which EMA, from March and October, tried to find solutions. The greatest inconveniences concern Ireland and North Ireland, lands of clash between Europe and United Kingdom, which needed many clarifications about the application ofBrexit protocols. The UK authorization to function as a hub for the drug distribution in North Ireland and other measures to avoid pharmaceutical deficiency in this country are just some of the main talking points.

On 1st of April, AIFA releases a paper about drugs active substances imports from UK , y paying particular attention to North Ireland.


About nitrosamines, in October, EMA publishes a revision, with the introduction of two new drugs to find more clarifications in their test executions.

Medical devices

In October, the Medical Device Coordination Group (MDCG) releases a guidance on classification of medical devices and a couple of explanatory notes to clarify the regulations. In June-July EMA publishes guidelines and pratical remarks for drug usage by mean of medical devices.


On September 8th, because of some rised issues from pharmaceutical agencies, EMA releases a concluding paper about the impact of the removal of titan dioxide from the list of authorized excipients. The document estalishes a ten years period of transition. IPEC Europe, on the other side, publishes a validation guide for manufacturers about excipients,which considersthe main guidelines.


EMA released several papers about GMP world: in April, the one containing for CMP (Certificate of a Medicinal Product); in May, the one about armonization between european and brasilian regulatory authorities; on July 23th, the final version of the reflection paper about GMP and MAH was published; onSeptember 18th, the new version of the paper for cooperation and armonization among the GMP/GDP inspectorates of European Union , starting from July 26th, was released. For the latter, the most relevant news is about a detailed list of faults, grouped in risk cathegories, and a section about the most severe and repeted non-compliance management.

Lastly, on September 30th, has been approved an announcement, that AIFA received on October 4th, extending the GMP/GDP certificates validity to the end of 2022, ensuring the chance of Distant Assessment for new sites which have not been used yet and for the prolongation of temporary GMP/GDP flexibility, necessary tools during a pandemic (but, probably will not be adopted by default).

AIFA minds the GMP topic too. Indeed, it releases an announcement about data transfert from EudraGMDP to EMA OMS system (Organisation Managment Service). From January 28th 2022 autorithies will not use the previous system anymore.

About non-EU countries: in July FDA releases the final guidelines about field alert reports (FAD); in August, defective medicines guidelines are presented by british agency MHRA; in September IFPMA publishes a paper in order to shed light on the usage of CPP (Certificate of a Pharmaceutical Product).


In January AIFA releases a clarification about medicines labelling and waste connected to pharmaceutical production. Confindustria section about medical devices and some other associations responded by declaring the non-applicability in what is in their competence, bacause of the health interest prevalence with respect to the environmental issue.

Cleaning validation

In February APIC gives directives about cleaning validation in the factories where API are produced.


In March, the Indian Pharmaceutical Alliance releases a paper about best practices when dealing with visual inspection of sterile products.

Supply chain

In May EMA releases a paper into which frequent questions about parallel distribution are collected, while in June FDA publishes papers concerning different aspects of the supply chain: product identification by mean of labels and barcodes, definitions of suspicious and illegitimate productidentification and notification of a suspicious product and traceability system.


From March to November AIFA releases some clarification about biologics active ingredients. In particular, a new API BIO form has been raised. In order to gain the authorization, it will be necessary to express information about the active ingredient content in the drug.


In May FDA released two guidelines for ICH Q12: one is about products implementation and the other contains some technical and regolatory considerations. These guidelines have raised some concerns in the sector, because they are considered too much restrictive. In August ICH Q13 is presented.

Quality control

On May 25th, AIFA authorised to take just 3 active ingredients samples and excipient, instead than 5.

Overseas FDA releases in August the guidelines for analytical procedures which provides the use of NIR. In September a guidance full of considerations about microbiological quality in non-sterile products is published.

Medicinal gases

In July, Organizzazione Mondiale della Sanità releases a draft of a paper concerning medicinal gases GMP, of which request has incredibly increased because of COVID-19.

Veterinary drugs

On July 29th and August 3rd, AIFA published two papers containing the updates about veterinary drugs GDP.

Clinical studies

In September EMA releases a Q&A document about the new clinical trials regulations, which will be valid since 31/01/2022 and will provide a 3 years transition period.

New regulations: what is new about Annex 1

Leonardo Gabrieli cites Annex 1. From March to MAy, indeed, pharmaceutical associations sent many letters to EMA, in order to request corrections to the Annex 1 draft. Piero Iamartino, AFI referent with EIPG (European Industrial Pharmacist Group), goes into details about this theme, which has already been discussed during the AFI 2021 Simposium session about production.

The first draft on December 20th 2017had already caused stir. Indeed, about 6200 comments from european pharmaceutical associations reached EMA. It was then published the second draft, reviewed and corrected on the bases of the notes received. It has been released on February 20th 2020 (version n.12), but still, there have been some critics.

Associations sent a letter on March 14th, to which EMA did not reply, as Iamartino explained in July session. On November 15th, the associations wrote another letter to make themselves heard. In this paper, they reaffirmed the issues connected to the implementations of the new requirements needed, and about the probable impact one routinary drug production. Moreover, pharmaceutical associations reminded the necessity of training activity, to better understand new requirements, and obviously they asked for an appropriate technical time to act, after the entry into force of the regulation.

Attention remains high since the importance of Annex 1, which will become an international standard measure for sterile medicines production.

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