{"id":15568,"date":"2022-03-08T00:00:00","date_gmt":"2022-03-08T00:00:00","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/api-reshoring-and-regulatory-complexity\/"},"modified":"2023-08-28T14:26:40","modified_gmt":"2023-08-28T14:26:40","slug":"api-reshoring-and-regulatory-complexity","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/manufacturing\/api-excipients\/api-reshoring-and-regulatory-complexity\/","title":{"rendered":"API: reshoring and regulatory complexity"},"content":{"rendered":"\n

Pandemic emergency hit vigorously pharmaceutical production, by highlighting both the strenghts and weaknesses, uncovering future challenges. Two of theese latter are the main topic of the AFI Symposium session, on June 10th<\/sup>, 2021, for API production:<\/strong> relevant aspects for an operative and strategic management<\/strong>. The first of them is about the importance of active pharmaceutical ingredients (API) in the scope of European pharmaceutical strategy; while the second is about production management (with all the fulfilments connected to it), during a crisis.  <\/p>\n\n\n\n

Aschimfarma and active pharmaceutical ingredients<\/h2>\n\n\n\n

Active <\/strong>pharmaceutical <\/strong>ingredients <\/strong>is a strategic field that could have a great development in the next few years, because of actual facts.  <\/p>\n\n\n\n

Around this statement, Paolo Russolo<\/strong>, Aschimfarma<\/strong> President, start the discussion in this AFI Symposium session 2021<\/strong>.<\/p>\n\n\n\n

Aschimfarma includes 48 Italian and multinational enterprises. Theese are companies invoicing 2 billions \u20ac\/years, that are involved in active ingredients production, thanks to industrial processes, characterized by an incredible technology. In this field, Italy is at the top in the word market since it exports >85% of its production in >90 countries.<\/p>\n\n\n\n

European pharmaceutical strategy<\/h2>\n\n\n\n

In such a depiction, active ingredients manufacturers <\/strong>are in a key position to assure medicines availability and to tackle deficiencies. However, Asian countries competition determined a weakening in the active <\/strong>pharmaceutical<\/strong> ingredients<\/strong>, in Europe, in previous years, together with an increasing dependency from the availability of the ready-to-deliver medicine.<\/p>\n\n\n\n

While in the past, European role in pharma production was globally crucial, now, supply chain<\/strong> depends for more than 74%<\/a> from supplies coming from Asia. Theese numbers exposed UE to remarkable risks, especially in the first phases of pandemic.<\/p>\n\n\n\n

European pharmaceutical strategy identifies a way for healthcare industry autonomy, among the key-goals. To help with this purpose, the Commission launched a target initiative to identify the causes of vulnerability of pharmaceutical supply chain and a solution proposal, in order to increase resilience.<\/p>\n\n\n\n

Drugs reshoring and active ingredients in Italy<\/h2>\n\n\n\n

According to Aschimfarma, European health autonomy will depend largely on its ability to maintain and develop its industrial base, and of course, to invest in innovative and sustainable technologies\u201d  with this in mind, together with some other Italian supply chain famous associations (Egualia<\/strong> and Farmindustria<\/strong>), Aschimfarma presented the medicines and active ingredients reshoring project in Italy<\/strong>, coordinated by ALISEI Cluster<\/strong>.<\/p>\n\n\n\n

New regulatory fulfilments<\/h2>\n\n\n\n

From one side, the urgency of strengthening this field is getting more intense day by day, on the other, regulatory fulfilments keep increasing.<\/p>\n\n\n\n

New requirements in quality management<\/strong> lead to a reorganization in operative modalities, which impacted on production structure.<\/p>\n\n\n\n

From this point of view, the main regulatory aspect is the one of the application of the risk analysis in the facilities solution choices, since it imposes a validation, both for quality (dedicated or multi-purpose facilities) and for safety (containment), but especially about critical API<\/strong>.<\/p>\n\n\n\n

Risk analysis<\/h2>\n\n\n\n

Last regulatory updates about active ingredients production introduced risk analysis in the management of the facilities choices.<\/p>\n\n\n\n

Producers fulfilments include the submission to documents attesting that new production will not impact on production, and vice versa. Luisa Torchio<\/strong>, member of the Quality\/Normative<\/strong> Aschimfarma Commission<\/strong>, explains that the intent is to promote a balance between authorized productions and those that still have to be authorized.<\/p>\n\n\n\n

Risk analysis is regulated by the May 28th<\/sup> 2018 Health Ministerial Decree, <\/a>which repealed the 27th<\/sup> May 1999 Decree, and acknowledges its core in the Risk Evaluation Paper<\/strong>.<\/p>\n\n\n\n

The special requirement<\/h2>\n\n\n\n

The regulatory introduced the concept of special requirement<\/strong>, a feature associated to the product whose authorization is requested. The special requirement concerns sterilized products, antibiotics, radiotherapies, living cells, cytotoxic components or any substance associated to particular risks.<\/p>\n\n\n\n

To request the authorization of a new space for production of sterilized active substances, biologics or tissues derived, organs or human\/animal fluids (even with clinical trial purpose), the producing company must apply with 392\/01<\/strong> Model <\/strong>andsending the required papers, apart from 031\/04 Model<\/strong>.<\/p>\n\n\n\n

Risk assessment for critical API<\/h2>\n\n\n\n

For critical substances, risk assessment <\/strong>must be entirely introduced, which means that it cannot be presented just by summary<\/strong> (as requested for substances not included in this cathegory). It has to be drafted by the Qualificate Person<\/strong> encharged.<\/p>\n\n\n\n

All the risk factors have to be considered: <\/p>\n\n\n\n