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A line or stroke across something, as across the letter “t."
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Having a pattern of dots, as in the lowercase letter “i."
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A stroke normally made in a downward direction
High alert medications
Drugs that bear a heightened risk of causing significant patient harm when used in error.
INN
International Non-proprietary Names
LASA
Look–alike /Sound-alike
NCC MERP
National Coordinating Council for Medication Error Reporting and Prevention.
Qualifiers
A word, phrase or letter string that is used to help further define an invented name.
SFDA
Saudi Food & Drug Authority
SPC
Summary of Product Characteristics
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The purpose of this document is to provide guidance to pharmaceutical companies and other stakeholders on the key factors that should be considered when selecting an invented name for a medicinal product. The goal is to help minimize the risk of medication errors by ensuring invented names are clear, distinct, and do not pose a danger of confusion. The Drug Sector of the Saudi Food & Drug Authority (SFDA) has developed this guidance to assist companies in the naming process for new medicinal products. Careful consideration of the recommendations outlined here can help prevent medication mix-ups and enhance patient safety.
This guidance allows for the name of a medicinal product to be either an invented name that is distinct from and not easily confused with other invented or generic names, a scientific name of the active ingredient, or a scientific name accompanied by a trademark or the name of the marketing authorization holder. This guidance document is intended for applicants who are submitting a new proprietary name for a medicinal product, or applying for renewal or variation of an existing name. The objective is to assist applicants in the process of selecting an appropriate invented name for their medicinal product, in order to mitigate the risk of medication errors.
Applicants are expected to carefully review the proposed invented name against the criteria outlined in this guidance, before requesting that the name be considered for approval. Adherence to these recommendations can help prevent issues that may otherwise lead to medication errors.
The scope of this guidance document is to provide applicants with recommendations on the key criteria that will be applied when reviewing proposed invented names for medicinal products intended for human use.
This document should be read in conjunction with the following Drug Sector documents:
- The GCC Data Requirements for Human Drugs Submission.
- Guidelines for Variation Requirements.
- Guideline on Good Pharmacovigilance Practices (GVP).
- Guidance for Medication Error Reporting.
The SFDA assesses each proposed invented name to minimize the risk of confusion with the name of another medicinal product. Obtaining a trademark for the proposed invented name is not considered sufficient justification for accepting a proposed invented name.
The invented name of a medicinal product should not have potential look-alike and sound-alike (LA/SA) similarity, which could cause confusion in print, handwriting, or speech with the invented name of another medicinal product or international non-proprietary names (INN). When assessing the potential for such confusion between two names the following criteria present in table 1 should be considered:
Table1: Criteria Used to Identify Product Names that Look or Sound Similar to a Proposed Invented Name
In addition to similarity of the names, similarity in the product characteristics between two products may increase the risk of confusion and should be systematically assessed by the applicant.
These product characteristics include:
- Indication(s).
- Patient population(s).
- Prescriber (e.g., specialist).
- Dosage form(s).
- Dose.
- Dosage units.
- Route(s) of administration.
- Dosage strength(s).
- Storage conditions.
- Contraindication.
- Clinical setting for dispensing and use (e.g., restricted to hospital setting).
The applicant should also assess the risk of harm (e.g. high alert medications). The Applicant should check the Institute for Safe Medication Practices (ISMP) “List of High-Alert Medications in Acute Care Settings5" website to determine which drugs fall under the high alert category.
Obvious Similarities in Spelling and Pronunciation of Proprietary Names:
Generally, proposed proprietary names should not be similar in spelling or pronunciation to other proprietary names, established names, or active ingredients of other registered products at SFDA.
Inert or Inactive Ingredients:
Proprietary names should not incorporate any reference to an inert or inactive ingredient in a way that creates the impression that the ingredient's value is greater than its true functional role in the formulation.
The Applicant is expected to review INN use before requesting that the proposed invented name(s) be considered.
The invented name should not incorporate an exact INN stem in the stem position for that drug. This is in accordance with World Health Assembly Resolution (WHA) 46.19, which states that an invented name should not be derived from its own INN.
Additionally, use of an INN that designates a different drug class should also be avoided, as it may be misleading (e.g., practitioners may think the drug is from another pharmacologic class).
By including the same INN stem in the invented name as the INN, healthcare professionals could consider that this is a new active substance as opposed to an invented name; by including a different INN stem healthcare professional could consider that this is a different class of medication rather than an invented name.
The use of a two letter INN stem in an infix or suffix position in an invented name will be addressed on a case by case basis.
A full list of INN stems is available on the WHO website: https://www.who.int/medicines/services/inn/stembook/en/
United States Adopted Name (USAN) Stems
USAN stems are intended to indicate a pharmacological or chemical trait of a drug, and a single stem may be applicable to multiple drug products.
Proprietary names should not incorporate USAN stems in the position that USAN designates for the stem (e.g., Drugostatin) as this can result in the creation of multiple similar proprietary names and/or proprietary names that are similar to established names.
According to the WHO and USAN, the well- established stem should not be used in or as trademarks.
The applicant should submit one proposed (invented) name for each medicinal product. Drug sector will review the name and if it is not acceptable, the company will be asked to provide another name.
General Principles
The applicant should use the principles below to aid in the development of the invented name:
1. The invented name should not be liable to confusion with the generic or the invented name of any other medicinal product.
2.The invented name should not be liable to confusion with other names of products, which were withdrawn from the market.
3.The invented name should not be misleading with respect to promotional issues and make claims relevant to:
- Overstatement of product efficacy,
- Minimization of risk,
- Broadening of product indication,
- Unsubstantiated superiority claims, or
- Being overly fanciful.
4.The invented name of a medicinal product should not incorporate product-specific attributes such as:
- Dosing intervals (e.g. NameBID)
- Dosage form (e.g. NameTab)
- Route of administration (e.g. Nameoral)
5.If the medicinal product contains more than one active ingredient, the invented name should suggest all the ingredients, not just some of them, or it may be considered misleading.
6.If the invented name includes the name of an ingredient which is not contained in the medicinal product, it will be considered misleading.
7.Invented name should not incorporate the manufacturer's full name or part of the name across multiple products, as this may increase the similarity of invented names by the same company.
8.Biological medicinal products follow the same criteria applied for any other medicinal products in respect to the (invented) name.
The following terms which form part of the invented name will only be considered where the specified conditions are met by the applicant. Derivatives of the listed terms with regards to spelling and other connotations, if misleading, will not be approved:
- Fast acting, Express: (including derivatives such as Xpress) and any other terms indicating a 'quick' or 'fast' onset of action should only be used where this claim is supported by data in the SPC and is relevant to the indication(s) for which the product is being marketed (e.g., onset of action in < 30 minutes from oral administration);
- Once-a-day: should only be used where a unit dose is taken or administered once in a day. Half-a-tablet twice a day, with the justification that the total dose per day is equivalent to one tablet is not acceptable. Once-a day may be used where one or more tablets are taken or administered once a day;
- PLUS, Extra: (including derivatives such as Xtra) should only be used where the medicinal product contains an additional active ingredient which confers a synergistic or additional therapeutic action or benefit;
- Triple action: should only be used where the medicinal product clearly has three different therapeutic actions. This may be a product with a single active substance with three different actions or three active ingredients with different modes of action. Where the claim has a qualified therapeutic action, (e.g., 'Triple action pain relief'), the three different actions must be relevant to pain relief;
- Advance: should only be used when it can be demonstrated that enhancement has been achieved with the new product compared with the existing product. This may be an enhancement in a therapeutic action or enhancement resulting from a formulation change. The addition of increased amounts of the active ingredient and/or excipient(s) without evidence of enhanced therapeutic benefit is not acceptable justification; similarly, minor changes in formulation that do not provide recognizable benefits over the existing product do not constitute enhancement;
- Maximum strength: should only be used where there are different strengths of products containing the same ingredient and the strength is the maximum available;
- Flavors: have to be identified as such, (e.g. the term 'strawberry' in a name is acceptable if there is fruit or natural extract contained in the product; if present as an artificial flavoring will have to be listed as 'strawberry flavor' in the product name).
Applicant should provide justification to the SFDA when requesting a qualifier.
6.1. Composition of the Qualifier
The use of qualifiers/abbreviations by letters as part of the invented name is, in principle, acceptable. Proposed qualifiers should not consist of a single letter or number (Arabic and Roman), because they may be confused with the strength and/or posology of the medicinal product. Numbers in general should only be used to indicate the strength of the medicinal product. In certain cases, a number(s) may form part of a qualifier; however, this would be assessed on an individual basis.
6.2. Selection of a Qualifier or Abbreviation
The following should be considered when proposing a qualifier/abbreviation:
- Whether the qualifier/abbreviation provides further information on characteristics of the medicinal product (e.g. duration of action, device, route of administration, composition, patient population) or provides for a differentiation, which may help healthcare professionals and/or patients to prescribe/select the appropriate medicinal product.
- The potential risk to public health in case of a medication error potentially related to the qualifier/abbreviation versus the potential risk resulting from a more complex name or completely different name.
6.3. Prolonged-release Preparations
Applicants are advised that the following suffixes should be used for prolonged release preparations, as appropriate to the particular product:
•CR – Controlled release.
•LA – Long acting.
•PR – Prolonged release.
•SA – Sustained action.
•SR – Sustained release.
•XR – Extended release.
•XL – Prolonged release, once daily dosing. If a product can be given once or twice daily, a different suffix should be used.
MR – Modified release: The use of MR for a prolonged release preparation is no longer recommended. Modified release can indicate a gastro-resistant product or a prolonged release product, therefore the term is not specific for an individual product.
6.4. Gastro-resistant Preparations
Applicants are advised that the following suffixes should be used for gastro- resistant preparations, as appropriate to the particular product:
•EC – Enteric coated.
•GR – Gastro resistant.
6.5. Incorporation of Company’s Name
• Proprietary names should not incorporate the company’s name, or some part of the company’s name across multiple products. This practice results in creating multiple similar proprietary names, increasing the risk of confusion across products.
• If the company submits a generic name plus either an abbreviation of a company or full name after the generic name (not attached to the name), this will be accepted, for example: Cepecitabine SFDA.
• If the company submits a invented name attached to the company’s abbreviation either on the beginning or at the end of the name this will be rejected, for example: CefaSFDA.
• If the company submits a invented name that includes both the invented name and the company name (e.g. Moxavel SFDA), the name will be rejected. In this case, the company has two options:
•Delete the company name, leaving just the invented name (e.g. Moxavel).
•Replace the invented name with the generic name, while keeping the company name (e.g. Moxifloxacin SFDA).
• If the company submits a generic name along with either an abbreviated company name or the full company name at the beginning, this combination will be rejected. For example, "SFDA Atenolol" would be rejected.
• The company must provide the complete generic name for the proposed invented name to be considered acceptable. If the company submits only a partial or abbreviated version of the generic name, rather than the full generic name, the submission will be rejected.
It is highly recommended in order to facilitate SFDA's consideration of the assessment of proposed product name; applicants should consider and address the type of factors listed below in their application. A risk analysis for the new application, taking into account all of these points, and considering the impact on existing products would facilitate SFDA consideration. Applicants should address how they propose to deal with any potential risks identified or explain why, in their opinion; the identified risks would not present a problem.
The applicant should examine and include information in its application using the following criteria:
- Description of other products within the company's own range. The company should review the new invented name and compare it with other companies' products names for LA/SA similarity.
- The company should assess the invented product name for LA/SA potential with all other drugs registered in Saudi Arabia (registered drug list is available at SFDA's website or per request).
- Derivation of names (how did the company choose the name and is there any meaning of the name).
- Invented meaning of name and modifier (definitions of symbols or abbreviations if it is included in the name).
- Use of different suffixes/prefixes etc.
- Therapeutic class of drug.
- The Invented name should not contain number
- Care environment for dispensing and use (area in which the drug is utilized).
- Delivery system and measuring device (if the product needs a device for use, the company should address the device used and how it measures).
- Prescriber.
- Frequency.
- The route(s) of administration.
- Any special consideration regarding the drug product (e.g. for IV use only).
- Harm (e.g. high alert medications which are drugs that bear a heightened risk of causing significant patient harm when they are used in error).
In the case of a product name variation (Refer to The Guidelines for Variation Requirements), the company needs to provide justification(s) for this change and do above mentioned assessment steps.
If the proposed name is rejected, the company is committed to submit updated file with the new name after fulfilling all registration requirements.
If medication errors resulted from the invented names of medicinal products (e.g., mix-ups with other products), such incidents should be reported through the established pharmacovigilance systems of the marketing authorization holders and should be reported to the SFDA in accordance with Guideline on Good Pharmacovigilance Practices (GVP). Incidents shall be reported via the Vigilance System at https://ade.sfda.gov.sa/Organization/Login and in accordance with the Guidance for Medication Error Reporting.Furthermore, it should be recognized that when product names convey misleading therapeutic connotations, there may be a risk of misuse or abuse of the product. Where such misuse or abuse results in medication errors, reporting through the pharmacovigilance system is still applicable.
Approval of a name by the SFDA does not relieve the applicant of its responsibility should actual or potential hazards come to light following marketing of the product. In these circumstances, the SFDA must be advised and appropriate action taken.
1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.2. PDUFA Pilot Project Proprietary Name Review – Concept paper, September 2008. Available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm3. Guideline on the acceptability of names for human medicinal products processed through the centralized procedure, EMA/CHMP/287710/2014-Rev. 64. MHRA Guideline for the naming of Medicinal products and Braille requirements for name on label, May 2009.5. National Coordinating Council for Medication Error Reporting and Prevention.6. Institute for Safe Medication Practices (ISMP), List of High- Alert Medications in Acute Care Settings.
Last update: 13 August 2024
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