According to a report published Monday, trade associations, manufacturers, universities and researchers gave their opinion on the draft strategy of the UK Medicines and Health Products Regulatory Agency (MHRA) for standards development. pharmacological.
In general, the MHRA argues that the value of standardization has been confirmed and that standards could add value, including providing guidance and ensuring consistency of product characterization and quality control, ensuring the performance of standards. analytical methods and facilitate the development of bioanalytical methods.
context
In January, the MHRA asked for comment on its strategy as more organic products entered the market and the regulator sought to become "a precursor and precursor of innovative approaches to standardizing biological drugs."
MHRA has established a five-year strategy for biological pharmacological standards, with a first step in comparing its current approach to the development of biological monographs with alternative procedures. The regulator is also planning to identify gaps and weaknesses in its current portfolio of standards and strengthen its understanding of these needs, including strengthening industry linkages and knowledge of how manufacturers control quality. products.
These and other activities will require the MHRA and its regulatory units, the National Institute of Biological Standards and Control and the British Pharmacopoeia, to pool their resources.
Earlier this year, a group of government agencies was established to help implement the strategy, including experts from the MHRA, UK Innovation Office, British Pharmacopoeia and NIBSC.
Consultation Comments
MHRA says: "It was clear that many stakeholders felt that both the type and function of" standards "were essential to ensure they were fit for purpose."
For example, for biotechnologically produced proteins, comments indicated that standards "should not be unnecessarily restrictive and allow the development of new products and technologies over time", while recognizing the specific nature of these concepts standardization products.
For Advanced Therapy Medicine (ATMP), commentators stated, "Due to the emerging nature and complexity of this product category, it is important that the standards developed are not unnecessarily restrictive and do not impede key areas in which standards could add value would be the development of a common understanding and the coherence of testing methodologies. "
The MHRA also noted that for ATMPs, "there was a strong preference for non-mandatory guidance, including standards for specific analytical technologies and techniques supported, as appropriate, by physical standards.
A number of interest groups also suggested exploring two new concepts for complex biological drugs, such as monoclonal antibodies, although MHRA notes that they were previously recommended in an International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the European Generics Association (EGA) 2014.
Setting the standards for raw materials has also been "widely recommended," MHRA said. "Control of raw materials was considered important because its properties could influence the critical quality attributes of bulk biological substances."
Looking ahead, the MHRA reports that it will hold a symposium in 2018 on the progress of its work on pharmacopoeia standards and that annual updates will be provided through symposia or online events.
Tuesday, October 24, 2017
Tuesday, October 10, 2017
EMA Adds New Excipients to Labeling Requirements
The European Medicines Agency (EMA) updated on Monday its annex to the European Commission guidelines on the labeling of excipients, adding five new excipients and extending the safety warnings required for 10 others.
Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are considered inactive, although some may cause reactions under certain circumstances. For example, lactose is commonly used as a filler in tablets, but may cause reactions in patients lactose intolerant.
This document lists excipients known to have a recognized action or effect and is to be declared on the label and package leaflet, is being updated for the first time since its publication in 2003.
The update also comes at a time when the European Commission is considering revising its guidelines on the labeling of excipients following a public consultation that ended in May.
The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and perfumes containing allergens. The appendix includes an appendix listing 26 specific perfume allergens such as cinnamon and oak moss that must be included in the labeling.
Regarding new safety information, the EMA indicates that the revised Annex "pays particular attention to ... the safety of these excipients when used in children or pregnant women". For example, the appendix contains new safety information that should be included in the package leaflet for benzyl alcohol-containing medicines that advise pregnant or lactating women to consult with their doctor or pharmacist before taking the drug.
The EMA indicates that the revised Annex enters into force immediately for all centrally and nationally authorized medicinal products and that current marketing authorization holders are required to update the labeling of their products at the first opportunity. For products that are not subject to regulation, the EMA indicates that developers are required to submit a Type IB variant detailing labeling changes over the next three years
Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are considered inactive, although some may cause reactions under certain circumstances. For example, lactose is commonly used as a filler in tablets, but may cause reactions in patients lactose intolerant.
This document lists excipients known to have a recognized action or effect and is to be declared on the label and package leaflet, is being updated for the first time since its publication in 2003.
The update also comes at a time when the European Commission is considering revising its guidelines on the labeling of excipients following a public consultation that ended in May.
The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and perfumes containing allergens. The appendix includes an appendix listing 26 specific perfume allergens such as cinnamon and oak moss that must be included in the labeling.
Regarding new safety information, the EMA indicates that the revised Annex "pays particular attention to ... the safety of these excipients when used in children or pregnant women". For example, the appendix contains new safety information that should be included in the package leaflet for benzyl alcohol-containing medicines that advise pregnant or lactating women to consult with their doctor or pharmacist before taking the drug.
The EMA indicates that the revised Annex enters into force immediately for all centrally and nationally authorized medicinal products and that current marketing authorization holders are required to update the labeling of their products at the first opportunity. For products that are not subject to regulation, the EMA indicates that developers are required to submit a Type IB variant detailing labeling changes over the next three years
Sunday, October 1, 2017
ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation
The International Council of Harmonization (CIE) is considering two new issues, according to the report published Thursday at the group's Montreal meeting in May and June.
Both topics include the first review of ICH's 1997 General Clinical Trial Guidelines and a new directive on pediatric extrapolation in clinical trials proposed by the US Food and Drug Administration (FDA).
The ICH Assembly also adopted brainstorming tables for both topics and the FDA proposed to lead informal working groups to finalize concept papers and develop business plans to move forward with the guidelines.
During the meeting, the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a regulatory member and the Cooperation System for Pharmaceutical Inspection (PIC / S) as an observer of the group.
Progress in other guidelines
The minutes also detail the updates submitted to the ICH Assembly on other guidelines at different stages of development or review.
For the ongoing review of its Guidelines on Carcinogenicity Studies of Rodents, ICH S1 (R1), the Rapporteur of the Working Group of Experts informed the meeting that 40 carcinogenicity assessment documents have been compiled and summary reports of the regulatory authorities and the document is expected to reach Step 2a / b in June or November 2018.
The EWG of the forthcoming directive on non-clinical safety trials for pediatric medicines (S11) also indicated that it expects to finalize a Phase 1 document before the ICH meeting in Geneva, November, in November.
ICH guideline E17 on multiregional clinical trials is also expected to reach Stage 3 at the Geneva meeting and to reach Stage 4 at the meeting based on the result of a 5 6 days to review the comments in the guide.
Regarding the technical and regulatory considerations of ICH, P12 for the management of the life cycle of pharmaceuticals, the Assembly noted that the Phase 1 document should be subject to a legal review for the EU, here in the middle September 2017 before members can decide to approve the document for Step 2.
The informal working group of Guideline E19 for the optimization of safety data collection also reported that the guideline is expected to reach the first step in November 2018.
During the meeting, the ICH Assembly also approved work plans for the E2B Directive (R3) on the electronic submission of individual case safety reports, the M2 Directive on electronic standards for transfer, the M9 Directive on biopharmaceutical based products in the biopharmaceutical classification system and the M10 Directive on the validation of the bioanalytical method. It is also expected that the M9 and M10 Guidelines will reach Stage 1 in June 2018.
Both topics include the first review of ICH's 1997 General Clinical Trial Guidelines and a new directive on pediatric extrapolation in clinical trials proposed by the US Food and Drug Administration (FDA).
The ICH Assembly also adopted brainstorming tables for both topics and the FDA proposed to lead informal working groups to finalize concept papers and develop business plans to move forward with the guidelines.
During the meeting, the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a regulatory member and the Cooperation System for Pharmaceutical Inspection (PIC / S) as an observer of the group.
Progress in other guidelines
The minutes also detail the updates submitted to the ICH Assembly on other guidelines at different stages of development or review.
For the ongoing review of its Guidelines on Carcinogenicity Studies of Rodents, ICH S1 (R1), the Rapporteur of the Working Group of Experts informed the meeting that 40 carcinogenicity assessment documents have been compiled and summary reports of the regulatory authorities and the document is expected to reach Step 2a / b in June or November 2018.
The EWG of the forthcoming directive on non-clinical safety trials for pediatric medicines (S11) also indicated that it expects to finalize a Phase 1 document before the ICH meeting in Geneva, November, in November.
ICH guideline E17 on multiregional clinical trials is also expected to reach Stage 3 at the Geneva meeting and to reach Stage 4 at the meeting based on the result of a 5 6 days to review the comments in the guide.
Regarding the technical and regulatory considerations of ICH, P12 for the management of the life cycle of pharmaceuticals, the Assembly noted that the Phase 1 document should be subject to a legal review for the EU, here in the middle September 2017 before members can decide to approve the document for Step 2.
The informal working group of Guideline E19 for the optimization of safety data collection also reported that the guideline is expected to reach the first step in November 2018.
During the meeting, the ICH Assembly also approved work plans for the E2B Directive (R3) on the electronic submission of individual case safety reports, the M2 Directive on electronic standards for transfer, the M9 Directive on biopharmaceutical based products in the biopharmaceutical classification system and the M10 Directive on the validation of the bioanalytical method. It is also expected that the M9 and M10 Guidelines will reach Stage 1 in June 2018.
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