The European Medicines Agency (EMA) has updated a guideline on good pharmacovigilance practice (GVP) inspections to reflect changes to the rules on subcontractors.
Last year, the European Commission published an implementing regulation about the subcontracting of pharmacovigilance activities by marketing authorization holders. The change affected pharmacovigilance inspections, leading EMA and the Heads of Medicines Agencies (HMA) to update GVP guidance that had been in place since 2014.
Competent authorities can inspect third parties subcontracted to perform pharmacovigilance tasks, EMA and HMA said. The rule applies even if the third party’s obligation to agree to be inspected is absent from the subcontract.
EMA and HMA also updated the guidance in the light of experience with remote inspections. Under the revised guidance, the inspectorate may decide on a case-by-case basis whether a remote inspection will be sufficient to gain an adequate overview of the functioning of a pharmacovigilance system. Remote inspections may be performed when key pharmacovigilance sites are located outside the EU.
The guidance features new advice on pre-authorization inspections. In a new paragraph, EMA and HMA explain that authorities may conduct pre-authorization inspections to verify the accuracy and successful implementation of the pharmacovigilance system as the applicant described it in a filing for approval.
MedTech Europe pushes back against changes to single-use medical device rules
MedTech Europe has warned that making medical device reuse the default would create “a substantial regulatory burden.”
Under planned changes to the Medical Devices Regulation (MDR), manufacturers would need to justify why a single-use product cannot be reused. MedTech Europe, a trade group for medical device companies, said the justification requirement will create “redundant paperwork with no safety benefit” for the “large number of single-use devices that plainly cannot be reused.”
“Reprocessing of single-use devices should not become a regulatory default,” the trade group said. “The intended purpose of a device should remain determined by the manufacturer, in line with existing MDR requirements regarding clinical benefit, safety and performance, and the state of the art in medicine.”
MedTech Europe argued that the EU should pursue sustainability and circularity objectives “through dedicated environmental policy instruments that are better suited to transforming the healthcare ecosystem.” That approach would allow MDR to remain “grounded in scientific evidence, risk-based decision-making, and clearly allocated responsibilities,” the trade group said.
EFPIA partners with hospital pharmacists on 15-year move to single-unit barcoding
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has partnered with the European Association of Hospital Pharmacists (EAHP) to create guidance on a 15-year phased implementation of single-unit barcoding.
The partners plan to extend existing medicinal pack coding, as exemplified by the Falsified Medicines Directive, to the unit dose level. Under the plan, manufacturers will print barcodes on individual dose units such as vials, blisters, and bottles, provided in multiple-dose packages or for combination products. The barcodes will enable pharmacists to confirm the identity of a product after a multi-pack is separated.
EFPIA and EAHP identified two primary use cases for single-unit barcodes. First, the codes will enable bedside scanning to reduce medication errors. Second, the codes could make it easier for hospitals to enter medication administration into electronic patient records, increasing efficiency and reducing staff burdens.
The partners have established design criteria for the single-unit codes. While the European Medicines Verification System permits a compromise, EFPIA and EAHP will prohibit deviation from GS1 standards to minimize disruption of the European supply chain. The code will exclusively use the GTIN as the product identifier.
Single units will carry GS1 DataMatrix codes. Hospitals have shown a clear preference for codes to carry at least the GTIN, batch/lot information, and the expiry date, EFPIA and EAHP said. However, both sides acknowledge that the GTIN product identifier conveys most of the benefits of single-unit coding, with drugmakers and hospitals estimating it could resolve up to 90% of the ideal requirements.
Manufacturers can enable bedside scanning and reduce medication errors by providing basic codes that only encode the GTIN. Advanced codes that include batch/lot information and the expiry date will allow hospitals to automate the entry of medication administration into electronic patient records.
Basic codes have “advantages regarding the turnaround time with artwork changes and the ease with which the code can be applied to the unit dose,” the partners said. Such codes may be the only option when more detailed forms cannot be applied for manufacturing reasons, such as a lack of space. The guidance also covers codes that have human-readable information.
“Manufacturers must, regardless of the coding form adopted, ensure that the hospital sector can easily access the product information relating to the GTIN applied to each unit dose,” the partners said. “In all cases, early engagement with the regulatory authorities is required to minimize delays and potential issues.”
Under the guidance, all launches of new products will support advanced codes within five years. EFPIA and EAHP have established a longer transition for existing products, requiring 50% of medicines within the scope of the guidance to support at least basic coding within 10 years. The goal is for 80% of drugs to carry at least basic codes within 15 years.
Advocate General calls for EU to annul contentious aspect of wastewater regulations
A high-ranking legal expert at the Court of Justice of the European Union (CJEU) has called for the annulment of a requirement for pharma and cosmetics producers to pay for wastewater treatment.
Under the Urban Wastewater Treatment Directive, pharma and cosmetics companies must pay at least 80% of the costs for the quaternary treatment of urban wastewater to remove micropollutants. Officials put the burden on the two industries in the belief that they are the main sources of micropollutants and, as such, should pay for the removal of the public health hazards.
The industries and some European countries have pushed back against the requirement. Poland brought a legal case, arguing that the requirement fails to observe the polluter-pays principle and the principle of proportionality.
In an opinion on the case, CJEU Advocate General Juliane Kokott found fault with how EU institutions calculated the toxic load attributable to the pharma and cosmetics industries. The perceived failings informed Kokott’s recommendation that the court should annul the section of the directive that makes the two industries pay for removing micropollutants, and order EU institutions to pay Poland’s costs.
The recommendation is not binding for the final CJEU judgment. However, while the court could reach a different conclusion than Kokott, Medicines for Europe said the opinion strengthens the case for pausing implementation of the scheme. Medicines for Europe represents off-patent drugmakers. EFPIA, the large pharma trade group, also called for the European Commission to pause implementation.
While the payment requirements are scheduled to take effect at the end of 2028, Medicines for Europe said companies will need to decide which medicines to manufacture, how much to supply, and where to invest much sooner. Companies may withdraw products, reduce supply, or weaken European production. Pausing implementation would allow manufacturers to at least defer such decisions.
Legal Opinion, EFPIA Statement, More
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EMA’s Pharmacovigilance Risk Assessment Committee has begun reviewing a potential link between low blood phosphate levels and injectable iron-containing medicines. EMA Notic
